ClinicalTrials.gg
Sign In
CompletedNCT01665053Updated Jan 30, 2019Results posted

The EVOLVE II Clinical Trial To Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)

A Phase 3 interventional study of PROMUS Element Plus and SYNERGY in Coronary Artery Disease, sponsored by Boston Scientific Corporation. Completed at 126 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-30.

Sponsored by Boston Scientific Corporation · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,684
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to assess the safety and effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).

Read the detailed description

A concurrent, non-randomized, single-arm, pharmacokinetic (PK) substudy and a consecutive, non-randomized, single-arm, Diabetes substudy will also enroll under the EVOLVE II protocol.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • Drug-Eluting Stents
03

In context

Coronary Artery Disease

5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.

This study's enrollment of 1,684 is above the median of 123 across 3,481 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 527 studies on the registry; 40 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Browse Boston Scientific Corporation studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject must be at least 18 years of age
  • Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed
  • For subjects less than 20 years of age enrolled at a Japanese site, the subject and the subject's legal representative must provide written informed consent before any study-specific tests or procedures are performed
  • Subject is eligible for percutaneous coronary intervention (PCI)
  • Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia
  • Subject is an acceptable candidate for coronary artery bypass grafting (CABG)
  • Subject is willing to comply with all protocol-required follow-up evaluation

Angiographic Inclusion Criteria (visual estimate):

  • Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.25 mm and ≤4.0 mm
  • Target lesion(s) length must be ≤34 mm (by visual estimate)
  • Target lesion(s) must have visually estimated stenosis ≥50% and \<100% with thrombolysis in Myocardial Infarction (TIMI) flow >1 and one of the following: stenosis ≥70%, abnormal fractional flow reserve (FFR), abnormal stress or imaging stress test, or elevated biomarkers prior to the procedure
  • Coronary anatomy is likely to allow delivery of a study device to the target lesions(s)
  • The first lesion treated must be successfully predilated/pretreated

Exclusion criteria

Exclusion Criteria:

  • Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI)
  • Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina
  • Subject has received an organ transplant or is on a waiting list for an organ transplant
  • Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
  • Planned PCI (including staged procedures) or CABG after the index procedure

  • Subject previously treated at any time with intravascular brachytherapy

    _ Subject has a known allergy to contrast (that cannot be adequately premedicated) and/or the trial stent system or protocol-required concomitant medications (e.g., platinum, platinum-chromium alloy, stainless steel, everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin)

  • Subject has one of the following (as assessed prior to the index procedure):

    • Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 24 months
    • Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)
    • Planned procedure that may cause non-compliance with the protocol or confound data interpretation
  • Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, coumadin) for indications other than acute coronary syndrome
  • Subject has a platelet count \<100,000 cells/mm3 or >700,000 cells/mm3
  • Subject has a white blood cell (WBC) count \< 3,000 cells/mm3
  • Subject has documented or suspected liver disease, including laboratory evidence of hepatitis
  • Subject is on dialysis or has baseline serum creatinine level >2.0 mg/dL (177µmol/L)
  • Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
  • Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months
  • Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding
  • Subject has severe symptomatic heart failure (i.e., NYHA class IV)
  • Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
  • Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
  • Subject with known intention to procreate within 12 months after the index procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure)
  • Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)

Angiographic Exclusion Criteria (visual estimate):

  • Planned treatment of more than 3 lesions
  • Planned treatment of lesions in more than 2 major epicardial vessels
  • Planned treatment of a single lesion with more than 1 stent
  • Subject has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate)
  • Target lesion(s) is located in the left main
  • Target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate
  • Target lesion(s) is located within a saphenous vein graft or an arterial graft
  • Target lesion(s) will be accessed via a saphenous vein graft or arterial graft
  • Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
  • Target lesion(s) treated during the index procedure that involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)
  • Target lesion(s) is restenotic from a previous stent implantation or study stent would overlap with a previous stent
  • Subject has unprotected left main coronary artery disease (>50% diameter stenosis)
  • Subject has been treated with any type of PCI (i.e., balloon angioplasty, stent, cutting balloon atherectomy) within 24 hours prior to the index procedure
  • Thrombus, or possible thrombus, present in the target vessel (by visual estimate)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
1,684 participants (actual)

Study arms

  • Active comparator
    Promus Element Plus

    PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).

    Device: PROMUS Element Plus

  • Experimental
    SYNERGY

    SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).

    Device: SYNERGY

Interventions

  • DevicePROMUS Element Plus

    A drug eluting coronary stent system

  • DeviceSYNERGY

    A drug eluting coronary stent system

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Target Lesion Failure (TLF) at 12 Months

    TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death.

    Time frame: 12 months

Secondary outcomes

  1. Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months.

    The TLR overall rate includes: TLR Percutaneous Coronary Intervention (PCI) \& TLR Coronary Artery Bypass Graft (CABG).

    Time frame: 12 months

  2. Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months.

    TVR overall includes: TVR PCI \& TVR CABG.

    Time frame: 12 months

  3. Percentage of Participants With Target Vessel Failure (TVF) at 12 Month.

    Target Vessel Failure is defined as any ischemic-driven revascularization of the target vessel, MI related to the target vessel, or any cardiac death.

    Time frame: 12 months

  4. Percentage of Participants With Myocardial Infarction at 12 Month.

    The MI rate includes: MI's related to the Target Vessel, MI's with unknown relationship to the Target Vessel and MI's not related to the Target Vessel.

    Time frame: 12 months

  5. Percentage of Participants With Cardiac Death at 12 Month.

    Time frame: 12 months

  6. Percentage of Participants With Non-Cardiac Death at 12 Month.

    Time frame: 12 months

  7. Percentage of Patients That Died at 12 Months.

    The Death rate includes Cardiac- \& Non-Cardiac Death.

    Time frame: 12 months

  8. Percentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month.

    Time frame: 12 months

  9. Percentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month.

    Time frame: 12 months

  10. Percentage of Participants Who Died, Had an Myocardial Infarction (MI) or a Target Vessel Revascularization (TVR) at12 Month.

    Time frame: 12 months

  11. Percentage of Participants With a ARC (Academic Research Consortium) Stent Thrombosis Rate at 12 Month.

    Time frame: 12 months

  12. Percentage of Patients With a Stroke at 12 Month.

    The stroke rate includes: Ischemic- , Hemorraghic- \& Undetermined Stroke.

    Time frame: 12 months

  13. Periprocedural Technical Success Rate.

    Technical Success Rate is defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization, and post-procedure diameter stenosis less then 30% in 2 near-orthogonal projections with TIMI 3 flow in the target lesion. Technical success is lesion based.

    Time frame: Day 1 (periprocedure)

  14. Periprocedural Clinical Procedural Success Rate

    Procedural Success Rate is defined as post-procedure diameter less then 30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions without occurrence of in-hospital cardiac death, MI, TVR. Procedural success rate is subject based.

    Time frame: Day 1 (periprocedure)

  15. Percentage of Participants With a Target Lesion Failure (TLF) at 12 Month.

    Time frame: 12 month

  16. Percentage of Patients With Revascularization (=All Revascularizations) at 12 Month.

    All CEC adjudicated revascularization at 12 month (Intent to treat population).

    Time frame: 12 Month

07

Results

Posted Jan 7, 2016

Participant flow

A total of 1684 patients have been enrolled in the study Evolve II Randomizes Clinical trial (RCT) from 26 November 2012 until 29 Aug 2013. The Evolve II RCT study is anticipated to be completed (final 5-year follow-up) in 2018.

Participant flow — Overall Study
MilestonePromus Element PlusSYNERGY
Started838846
Completed 12-month clinical f/u797822
No 12-month f/u3215
Death with no 12-month clinical fu99
Completed806831
Not completed3215

Outcome measures

PrimaryPercentage of Participants With Target Lesion Failure (TLF) at 12 Months

TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death.

Time frame:
12 months
Reported as:
Number · percentage of participants
Percentage of Participants With Target Lesion Failure (TLF) at 12 Months
percentage of participantsPromus Element PlusSYNERGY
Percentage of Participants With Target Lesion Failure (TLF) at 12 Months6.46.4
SecondaryPercentage of Participants With Target Lesion Revascularization (TLR) at 12 Months.

The TLR overall rate includes: TLR Percutaneous Coronary Intervention (PCI) \& TLR Coronary Artery Bypass Graft (CABG).

Time frame:
12 months
Reported as:
Number · percentage of participants
Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months.
percentage of participantsPromus Element PlusSYNERGY
Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months.1.72.6
SecondaryPercentage of Participants With Target Vessel Revascularization (TVR) at 12 Months.

TVR overall includes: TVR PCI \& TVR CABG.

Time frame:
12 months
Reported as:
Number · percentage of participants
Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months.
percentage of participantsPromus Element PlusSYNERGY
Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months.3.63.8
SecondaryPercentage of Participants With Target Vessel Failure (TVF) at 12 Month.

Target Vessel Failure is defined as any ischemic-driven revascularization of the target vessel, MI related to the target vessel, or any cardiac death.

Time frame:
12 months
Reported as:
Number · percentage of participants
Percentage of Participants With Target Vessel Failure (TVF) at 12 Month.
percentage of participantsPromus Element PlusSYNERGY
Percentage of Participants With Target Vessel Failure (TVF) at 12 Month.8.28.2
SecondaryPercentage of Participants With Myocardial Infarction at 12 Month.

The MI rate includes: MI's related to the Target Vessel, MI's with unknown relationship to the Target Vessel and MI's not related to the Target Vessel.

Time frame:
12 months
Reported as:
Number · percentage of participants
Percentage of Participants With Myocardial Infarction at 12 Month.
percentage of participantsPromus Element PlusSYNERGY
Percentage of Participants With Myocardial Infarction at 12 Month.5.05.4
SecondaryPercentage of Participants With Cardiac Death at 12 Month.
Time frame:
12 months
Reported as:
Number · percentage of participants
Percentage of Participants With Cardiac Death at 12 Month.
percentage of participantsPromus Element PlusSYNERGY
Percentage of Participants With Cardiac Death at 12 Month.0.90.5
SecondaryPercentage of Participants With Non-Cardiac Death at 12 Month.
Time frame:
12 months
Reported as:
Number · percentage of participants
Percentage of Participants With Non-Cardiac Death at 12 Month.
percentage of participantsPromus Element PlusSYNERGY
Percentage of Participants With Non-Cardiac Death at 12 Month.0.20.6
SecondaryPercentage of Patients That Died at 12 Months.

The Death rate includes Cardiac- \& Non-Cardiac Death.

Time frame:
12 months
Reported as:
Number · percentage of participants
Percentage of Patients That Died at 12 Months.
percentage of participantsPromus Element PlusSYNERGY
Percentage of Patients That Died at 12 Months.1.11.1
SecondaryPercentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month.
Time frame:
12 months
Reported as:
Number · percentage of participants
Percentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month.
percentage of participantsPromus Element PlusSYNERGY
Percentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month.5.65.6
SecondaryPercentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month.
Time frame:
12 months
Reported as:
Number · percentage of participants
Percentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month.
percentage of participantsPromus Element PlusSYNERGY
Percentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month.5.86.3
SecondaryPercentage of Participants Who Died, Had an Myocardial Infarction (MI) or a Target Vessel Revascularization (TVR) at12 Month.
Time frame:
12 months
Reported as:
Number · percentage of participants
Percentage of Participants Who Died, Had an Myocardial Infarction (MI) or a Target Vessel Revascularization (TVR) at12 Month.
percentage of participantsPromus Element PlusSYNERGY
Percentage of Participants Who Died, Had an Myocardial Infarction (MI) or a Target Vessel Revascularization (TVR) at12 Month.8.49.3
SecondaryPercentage of Participants With a ARC (Academic Research Consortium) Stent Thrombosis Rate at 12 Month.
Time frame:
12 months
Reported as:
Number · percentage of participants
Percentage of Participants With a ARC (Academic Research Consortium) Stent Thrombosis Rate at 12 Month.
percentage of participantsPromus Element PlusSYNERGY
Percentage of Participants With a ARC (Academic Research Consortium) Stent Thrombosis Rate at 12 Month.0.70.6
SecondaryPercentage of Patients With a Stroke at 12 Month.

The stroke rate includes: Ischemic- , Hemorraghic- \& Undetermined Stroke.

Time frame:
12 months
Reported as:
Number · percentage of participants
Percentage of Patients With a Stroke at 12 Month.
percentage of participantsPromus Element PlusSYNERGY
Percentage of Patients With a Stroke at 12 Month.0.90.7
SecondaryPeriprocedural Technical Success Rate.

Technical Success Rate is defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization, and post-procedure diameter stenosis less then 30% in 2 near-orthogonal projections with TIMI 3 flow in the target lesion. Technical success is lesion based.

Time frame:
Day 1 (periprocedure)
Reported as:
Number · percentage of lesions
Periprocedural Technical Success Rate.
percentage of lesionsPromus Element PlusSYNERGY
Periprocedural Technical Success Rate.96.998.3
SecondaryPeriprocedural Clinical Procedural Success Rate

Procedural Success Rate is defined as post-procedure diameter less then 30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions without occurrence of in-hospital cardiac death, MI, TVR. Procedural success rate is subject based.

Time frame:
Day 1 (periprocedure)
Reported as:
Number · percentage of subjects
Periprocedural Clinical Procedural Success Rate
percentage of subjectsPromus Element PlusSYNERGY
Periprocedural Clinical Procedural Success Rate94.394.9
SecondaryPercentage of Participants With a Target Lesion Failure (TLF) at 12 Month.
Time frame:
12 month
Reported as:
Number · percentage of participants
Percentage of Participants With a Target Lesion Failure (TLF) at 12 Month.
percentage of participantsPromus Element PlusSYNERGY
Percentage of Participants With a Target Lesion Failure (TLF) at 12 Month.6.46.6
SecondaryPercentage of Patients With Revascularization (=All Revascularizations) at 12 Month.

All CEC adjudicated revascularization at 12 month (Intent to treat population).

Time frame:
12 Month
Reported as:
Number · percentage of patients
Percentage of Patients With Revascularization (=All Revascularizations) at 12 Month.
percentage of patientsPromus Element PlusSYNERGY
Percentage of Patients With Revascularization (=All Revascularizations) at 12 Month.3.64.0

Adverse events

Collected over Site-Reported Serious Adverse Events to 12 Months. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Promus Element Plus—262/838 (31.3%)576/838 (68.7%)
SYNERGY—265/846 (31.3%)567/846 (67%)
Most frequent serious events
Showing 10 of 24
Most frequent serious events
EventPromus Element PlusSYNERGY
Cardiac disordersCardiac disorders126/838143/846
General disorders and administration site conditionsGeneral disorders49/83845/846
Gastrointestinal disordersGastrointestinal disorders28/83815/846
Nervous sysytem disordersNervous system disorders18/83826/846
Injury, poisining and procedural complicationsInjury, poisoning and procedural complications23/83826/846
Infections and infestationsInfections and infestations23/83822/846
Respiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders20/83823/846
Vascular disordersVascular disorders20/83819/846
Renal and Urinary disordersRenal and urinary disorders15/83814/846
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Neoplasms benign, malignant and unspecified (incl cysts and polyps)14/83814/846
Most frequent other events
Showing 10 of 36
Most frequent other events
EventPromus Element PlusSYNERGY
Angina PectorisCardiac disorders104/838100/846
Myocardial infarctionCardiac disorders70/83874/846
DyspnoeaRespiratory, thoracic and mediastinal disorders40/83844/846
Coronary artery dissectionCardiac disorders27/83832/846
HypertensionVascular disorders30/83824/846
DizzinessNervous system disorders27/83830/846
HeadacheNervous system disorders21/83817/846
Pain in extremityMusculoskeletal and connective tissue disorders13/83821/846
HypotensionVascular disorders20/8389/846
Angina unstableCardiac disorders18/83820/846

Baseline characteristics

Age, Continuous
Age, Continuous(yr)Promus Element PlusSYNERGYTotal
Mean63.92 ± 10.5063.48 ± 10.4463.70 ± 10.47
Sex: Female, Male
Sex: Female, Male(Participants)Promus Element PlusSYNERGYTotal
Female229249478
Male6095971206
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Promus Element PlusSYNERGYTotal
American Indian or Alaska native213
Asian100100200
Black,of African heritage375289
Caucasian6646551319
Hispanic or Latino161531
Native Hawaiian or other Pacific Islander235
Other549
Not Disclosed132033
Region of Enrollment
Region of Enrollment(participants)Promus Element PlusSYNERGYTotal
Singapore121527
United States5065141020
Japan8174155
Spain201838
New Zealand131124
Canada5658114
Latvia121123
Netherlands131225
Austria213
Belgium5050100
Finland141630
Denmark91019
Poland459
Italy101121
Australia161733
France202343
Height
Height(inches)Promus Element PlusSYNERGYTotal
Mean67.44 ± 4.0767.23 ± 4.0067.33 ± 4.04
Weight
Weight(lbs)Promus Element PlusSYNERGYTotal
Mean190.45 ± 44.29190.92 ± 44.09190.69 ± 44.18
Smoking
Smoking(participants)Promus Element PlusSYNERGYTotal
Smoking, Ever5195101029
Smoking,Unknown121931
Smoking, Never307317624
Current Diabetes Mellitus
Current Diabetes Mellitus(participants)Promus Element PlusSYNERGYTotal
Current Diabetes Mellitus276275551
No Current Diabetes Mellitus5625711133

10 further baseline measures are reported on the registry.

08

Study locations

126 sites
  • Baptist Medical Center - Princeton
    Birmingham, Alabama 35211, United States
  • Banner Good Samaritan Medical Center
    Phoenix, Arizona 85006, United States
  • Arkansas Heart Hospital
    Little Rock, Arkansas 72211, United States
  • Bakersfield Memorial Hospital
    Bakersfield, California 93301, United States
  • University of California Davis Health System
    Sacramento, California 95617, United States
  • Sutter Memorial Hospital
    Sacramento, California 95819, United States
  • Alvarado Hospital Medical Center
    San Diego, California 92121, United States
  • North Colorado Medical Center
    Greeley, Colorado 80631, United States
  • South Denver Cardiology Associates, PC
    Littleton, Colorado 80120, United States
  • Washington Hospital Center
    Washington D.C., District of Columbia 20010, United States
  • Morton Plant Mease Healthcare
    Clearwater, Florida 33756, United States
  • University of Miami McKnight Brain Institute
    Miami, Florida 33138, United States
  • MediQuest
    Ocala, Florida 34471, United States
  • Florida Hospital Medical Center
    Orlando, Florida 32803, United States
  • Tallahassee Research Institute, Inc.
    Tallahassee, Florida 32308, United States
  • Medical Center of Central Georgia
    Macon, Georgia 31201, United States
  • Wellstar Health Systems
    Marietta, Georgia 30060, United States
  • Kaiser Foundation Hospital
    Honolulu, Hawaii 96819, United States
  • Kootenai Medical Center
    Coeur d'Alene, Idaho 83814, United States
  • Prairie Cardiovascular Consultants, Ltd.
    Springfield, Illinois 62701, United States
  • Northern Indiana Research Alliance
    Fort Wayne, Indiana 46804, United States
  • St. Vincent's Medical Group, Inc.
    Indianapolis, Indiana 46290, United States
  • Genesis Medical Center
    Davenport, Iowa 52803, United States
  • Mercy Hospital Medical Center
    Des Moines, Iowa 50314, United States
  • Kings Daughters Medical Center
    Ashland, Kentucky 41101, United States
  • Maine Medical Center
    Portland, Maine 04102, United States
  • MedStar Union Memorial Hospital
    Baltimore, Maryland 21218, United States
  • Tufts Medical Center, Inc.
    Boston, Massachusetts 02110, United States
  • Brigham & Women's Hospital
    Boston, Massachusetts 02120, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
  • Lahey Clinic Medical Center - Burlington
    Burlington, Massachusetts 01805, United States
  • Henry Ford Health System
    Detroit, Michigan 48202, United States
  • Genesys Regional Medical Center
    Grand Blanc, Michigan 48439, United States
  • Northern Michigan Hospital
    Petoskey, Michigan 49770, United States
  • St Mary's Duluth Clinic
    Duluth, Minnesota 55805, United States
  • Abbott Northwestern Hospital
    Minneapolis, Minnesota 55407, United States
  • North Mississippi Medical Center
    Tupelo, Mississippi 38801, United States
  • Saint Luke's Hospital of Kansas City
    Kansas City, Missouri 64111, United States
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
  • Deborah Heart and Lung Center
    Browns Mills, New Jersey 08015, United States
  • Our Lady of Lourdes Medical Center
    Haddon Heights, New Jersey 08035, United States
  • Morristown Medical Center
    Morristown, New Jersey 07960, United States
  • New Mexico Heart Institute, PA
    Albuquerque, New Mexico 87042, United States
  • Mount Sinai - PRIME
    New York, New York 10029, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
  • New York Presbyterian Hospital
    New York, New York 10065, United States
  • Moses H. Cone Memorial Hospital-LeBauer Cardiovascular Research Foundation
    Greensboro, North Carolina 27401, United States
  • Rex Hospital
    Raleigh, North Carolina 27607, United States
  • Wake Heart Research, LLC
    Raleigh, North Carolina 27610, United States
  • Wake Forest University
    Winston-Salem, North Carolina 27157, United States
  • Lindner Center for Research and Education at Christ Hosp
    Cincinnati, Ohio 45219, United States
  • University Hospitals Case Medical Center
    Cleveland, Ohio 44103, United States
  • Ohio State University Medical Center
    Columbus, Ohio 43210, United States
  • Mercy St. Vincent Medical Center
    Toledo, Ohio 43608, United States
  • Oklahoma Heart Hospital
    Oklahoma City, Oklahoma 73120, United States
  • Providence Portland Medical Center
    Portland, Oregon 97213, United States
  • Geisinger Clinic
    Danville, Pennsylvania 17822, United States
  • Pennsylvania Hospital
    Philadelphia, Pennsylvania 19107, United States
  • Temple University Hospital
    Philadelphia, Pennsylvania 19140, United States
  • Sisters of Charity Providence Hospitals
    Columbia, South Carolina 29204, United States
  • Jackson Madison County Hospital
    Jackson, Tennessee 38301, United States
  • Centennial Medical Center
    Nashville, Tennessee 37203, United States
  • Baylor Heart & Vascular Hospital
    Dallas, Texas 75226, United States
  • Medical City Dallas Hospital
    Dallas, Texas 75230, United States
  • St. David's Round Rock Medical Center
    Round Rock, Texas 78681, United States
  • Methodist Texsan Hospital
    San Antonio, Texas 78201, United States
  • Henrico Doctors Hospital
    Richmond, Virginia 23229, United States
  • Swedish Medical Center
    Seattle, Washington 98122, United States
  • Aspirus Heart & Vascular Institute
    Wausau, Wisconsin 54401, United States
  • The Prince Charles Hospital
    Chermside, Queensland 4032, Australia
  • Monash Medical Centre-Clayton Campus
    Clayton, Victoria 3168, Australia
  • St Vincent's Hospital Melbourne
    Fitzroy, Victoria 3065, Australia
  • Fremantle Hospital
    Fremantle, Western Australia 6160, Australia
  • LKH - Universitätsklinikum der PMU Salzburg
    Salzburg, Austria
  • AKH - Medizinische Universität Wien
    Vienna, Austria
  • Imelda Ziekenhuis
    Bonheiden, 2820, Belgium
  • Z.O.L - Campus St. Jan
    Genk, 3600, Belgium
  • UZ Leuven
    Leuven, 3000, Belgium
  • HHrm
    Roeselare, 8800, Belgium
  • Foothills Medical Centre
    Calgary, Alberta T2N 2T9, Canada
  • Hamilton Health Sciences
    Hamilton, Ontario L8L 2X2, Canada
  • Sunnybrook Health Sciences Centre
    Toronto, Ontario M4N 3M4, Canada
  • Institut de Cardiologie de Montreal
    Montreal, Quebec H1T 1C8, Canada
  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec
    Sainte-Foy, Quebec G1V 4G5, Canada
  • Rigshospitalet Copenhagen
    Copenhagen, 2100, Denmark
  • University Hospital, Heart Centre
    Tampere, 33521, Finland
  • Turku University Hospital
    Turku, FI-20520, Finland
  • CHU de Brest - Hôpital de la Cavale Blanche
    Brest, Finistere 29609, France
  • CHU de Toulouse - Hôpital Rangueil
    Toulouse, Haute Garonne 31059, France
  • Clinique Pasteur - Toulouse
    Toulouse, Haute Garonne 31076, France
  • Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel
    Bron, Rhone 69500, France
  • Clinique Saint-Hilaire - Centre Frédéric Joliot
    Rouen, Seine Maritime 76000, France
  • Polyclinique Les Fleurs
    Ollioules, Var 83192, France
  • Centre Hospitalier de Lagny - Marne La Vallée
    Lagny-sur-Marne, 77600, France
  • Hôpital Cochin
    Paris, 75014, France
  • Istituto Clinico Humanitas
    Rozzano, Milano 20089, Italy
  • Umberto I Pol. di Roma-Università di Roma La Sapienza
    Roma, 161, Italy
  • Azienda Ospedaliera Città della Salute e della Scienza di Torino
    Torino, 10126, Italy
  • Kokura Memorial Hospital
    Kitakyushu-shi, Fukuoka 802-8555, Japan
  • Kurume University Hospital
    Kurume-shi, Fukuoka 830-0011, Japan

Showing the first 100 of 126 sites across 16 countries.

09

References and documents

Publications

  • Kereiakes DJ, Windecker S, Jobe RL, Mehta SR, Sarembock IJ, Feldman RL, Stein B, Dubois C, Grady T, Saito S, Kimura T, Underwood P, Allocco DJ, Meredith IT. Clinical Outcomes Following Implantation of Thin-Strut, Bioabsorbable Polymer-Coated, Everolimus-Eluting SYNERGY Stents. Circ Cardiovasc Interv. 2019 Sep;12(9):e008152. doi: 10.1161/CIRCINTERVENTIONS.119.008152. Epub 2019 Aug 27. PubMed 31451014 ↗
  • Kereiakes DJ, Meredith IT, Windecker S, Lee Jobe R, Mehta SR, Sarembock IJ, Feldman RL, Stein B, Dubois C, Grady T, Saito S, Kimura T, Christen T, Allocco DJ, Dawkins KD. Efficacy and safety of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent: the EVOLVE II Randomized Trial. Circ Cardiovasc Interv. 2015 Apr;8(4):e002372. doi: 10.1161/CIRCINTERVENTIONS.114.002372. PubMed 25855680 ↗
10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2012, a primary completion of Sep 2014 and a completion of Dec 2018. It does not say whether these dates are actual or estimated.

Results were first posted in Jan 2016, 1 year 4 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 7, 2012
First posted
Aug 15, 2012
Start
Nov 2012
Primary completionActual
Sep 2014
CompletionActual
Dec 22, 2018
Results first posted
Jan 7, 2016
Last update
Jan 30, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01665053
Lead sponsor
Boston Scientific Corporation
Responsible party
Sponsor
First posted
Aug 15, 2012
Start date
Nov 2012
Primary completion
Sep 2014
Completion
Dec 22, 2018
Results posted
Jan 7, 2016
Last update
Jan 30, 2019

Study contacts

Peter M Maurer, MPH
study director · Boston Scientific Corporation

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Coronary Artery Disease →

Other studies from this sponsor

Boston Scientific Corporation →

Start the discussion