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CompletedNCT01913600RI-US XLUpdated May 8, 2019Results posted

Resolute Integrity US Extended Length Sub-Study(RI US XL)

An interventional study of Resolute Integrity Stent in Coronary Artery Disease, sponsored by Medtronic Vascular. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-08.

Sponsored by Medtronic Vascular · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Prospective, multi-center, non-randomized, single-arm, open-label study to assess the safety and efficacy of the Resolute Integrity Stent for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm in patients who receive extended length stents (34 mm or 38 mm) referred to as the Extended Length Study.

Read the detailed description

The purpose of this postapproval study is to conduct a prospective, multi-center evaluation of the procedural and clinical outcomes of subjects that are treated with the commercially available 34 mm and 38 mm Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System.

Descriptive statistics and 95% confidence intervals will be calculated for clinically relevant variables as described in a separate statistical analysis plan.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • TARGET LESION REVASCULARIZATION (TLR)
  • TARGET VESSEL REVASCULARIZATION (TVR)
  • Coronary Artery Disease
  • MYOCARDIAL INFARCTION (MI)
  • PERCUTANEOUS CORONARY INTERVENTION (PCI)
  • STENT THROMBOSIS
  • TARGET LESION FAILURE (TLF)
03

In context

Coronary Artery Disease

5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.

This study's enrollment of 56 is below the median of 123 across 3,435 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Medtronic Vascular is the lead sponsor of 58 studies on the registry; 7 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

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

Eligibility criteria

General and Angiographic Inclusion Criteria highlights:

  • Acceptable candidate for percutaneous coronary intervention (PCI),stenting, and emergency coronary artery bypass graft surgery
  • Clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study
  • Informed consent
  • Patient agrees to comply with specified follow-up evaluations
  • Single target lesion or two target lesions located in separate coronary arteries
  • De novo lesion(s) in native coronary artery(ies)
  • Target lesion(s) ≤ 35 mm in length
  • Target vessel(s) have reference vessel diameter 2.25 mm to 4.2 mm

General and Angiographic Exclusion Criteria highlights:

  • Within 7 days of index procedure platelet count \<100,000 cells/mm³ or >700,000 cells/mm³; White blood cell (WBC) count \<3,000 cells/mm³; serum creatinine level >2.5 mg/dl
  • Acute Myocardial Infarction (MI) within 72 hrs of the intended trial procedure (QWMI or any elevation of Creatine Kinase-MB (CK-MB) > lab upper limit of normal)
  • Previous PCI of target vessel(s) within 9 months prior to the procedure
  • Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of target vessel(s) within 12 months post-index procedure
  • History of stroke or Transient Ischemic Attack (TIA) within prior 6 months
  • Participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints
  • Inability to comply with required trial antiplatelet regimen
  • Previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent
  • Target vessel(s) has/have other lesions w/ > 40% diameter stenosis
  • Unprotected left main coronary artery disease
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • Other
    Resolute Integrity

    Resolute Integrity Stent

    Device: Resolute Integrity Stent

Interventions

  • DeviceResolute Integrity Stent

    Drug eluting stent (DES)

06

What researchers measure

Primary outcomes

  1. Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)

    The combined clinical outcome of (all cause) mortality, MI or any revascularization

    Time frame: 12 months

Secondary outcomes

  1. Composite Endpoint: Major Adverse Cardiac Events (MACE)

    Defined as death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods.

    Time frame: 30 days, 6 months, 12 months

  2. Composite Endpoint: Target Lesion Failure (TLF)

    Defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods

    Time frame: 30 days, 6 months, 12 months

  3. Composite Endpoint: Target Vessel Failure (TVF),

    The composite endpoint comprised of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.

    Time frame: 30 days, 6 months, 12 months

  4. Composite Endpoint: Cardiac Death and Target Vessel MI

    Combined rate of cardiac death and target vessel MI post-procedure

    Time frame: 30 days, 6 months, 12 months

  5. Composite Endpoint: Target Vessel MI

    Target-vessel MI is defined as a MI that occurs in a territory that cannot be clearly attributed to a vessel other than the target vessel.

    Time frame: 30 days, 6 months, 12 months

  6. Clinical Endpoint: Death

    All deaths including cardiac death, vasular death and non-cardiovascular death

    Time frame: 30 days, 6 months, 12 months

  7. Clinical Endpoint: Myocardial Infarction (MI)

    All myocardial infarction data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions.

    Time frame: 30 days, 6 months, 12 months

  8. Clinical Endpoint: Target Lesion Revascularization (TLR)

    Repeat Percutaneous coronary intervention (PCI) or Coronary artery bypass grafting (CABG) to the target lesion.

    Time frame: 30 days, 6 months, 12 months

  9. Clinical Endpoint: Target Vessel Revascularization (TVR)

    Repeat PCI or CABG of the target vessel.

    Time frame: 30 days, 6 months, 12 months

  10. Clinical Endpoint: Stent Thrombosis

    All stent thrombosis data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions

    Time frame: Early Thrombosis (<=30 days), Late Thrombosis (31-360 days)

  11. Clinical Endpoint: Stroke

    Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.

    Time frame: 30 days, 6 months, 12 months

  12. Clinical Endpoint: Bleeding Complications in General

    Bleeding complications in general including the GUSTO classification of Severe, Moderate \& Mild will be collected. The GUSTO scale defines clinical events that stratify bleeding episodes into mild, moderate or severe.

    Time frame: 30 days, 6 months, 12 months

  13. Dual Antiplatelet Therapy (DAPT) Compliance

    Protocol defined DAPT, Aspirin and Clopidogrel or Ticlopidine, at 30 days, 180 day and 360 days.

    Time frame: 30 days, 6 months, 12 months

07

Results

Posted Nov 17, 2017

Participant flow

56 XL subjects were enrolled from 9 study sites in the United States. The first subject was enrolled on July 26, 2013 and the last subject was enrolled on October 27, 2015.

Participant flow — Overall Study
MilestoneResolute Integrity US Extended Length Sub-Study (RI-US XL)
Started56
Completed55
Not completed1

Outcome measures

PrimaryComposite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)

The combined clinical outcome of (all cause) mortality, MI or any revascularization

Time frame:
12 months
Reported as:
Count of participants · Participants
Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)
ParticipantsResolute Integrity US Extended Length Sub-Study (RI-US XL)
Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)4
SecondaryComposite Endpoint: Major Adverse Cardiac Events (MACE)

Defined as death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods.

Time frame:
30 days, 6 months, 12 months
Reported as:
Count of participants · Participants
Composite Endpoint: Major Adverse Cardiac Events (MACE)
ParticipantsResolute Integrity US Extended Length Sub-Study (RI-US XL)
30 Days2
180 Days2
360 Days5
SecondaryComposite Endpoint: Target Lesion Failure (TLF)

Defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods

Time frame:
30 days, 6 months, 12 months
Reported as:
Count of participants · Participants
Composite Endpoint: Target Lesion Failure (TLF)
ParticipantsResolute Integrity US Extended Length Sub-Study (RI-US XL)
30 Days2
180 Days2
360 Days4
SecondaryComposite Endpoint: Target Vessel Failure (TVF),

The composite endpoint comprised of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.

Time frame:
30 days, 6 months, 12 months
Reported as:
Count of participants · Participants
Composite Endpoint: Target Vessel Failure (TVF),
ParticipantsResolute Integrity US Extended Length Sub-Study (RI-US XL)
30 Days2
180 Days2
360 Days4
SecondaryComposite Endpoint: Cardiac Death and Target Vessel MI

Combined rate of cardiac death and target vessel MI post-procedure

Time frame:
30 days, 6 months, 12 months
Reported as:
Count of participants · Participants
Composite Endpoint: Cardiac Death and Target Vessel MI
ParticipantsResolute Integrity US Extended Length Sub-Study (RI-US XL)
30 Days2
180 Days2
360 Days4
SecondaryComposite Endpoint: Target Vessel MI

Target-vessel MI is defined as a MI that occurs in a territory that cannot be clearly attributed to a vessel other than the target vessel.

Time frame:
30 days, 6 months, 12 months
Reported as:
Count of participants · Participants
Composite Endpoint: Target Vessel MI
ParticipantsResolute Integrity US Extended Length Sub-Study (RI-US XL)
30 Days2
180 Days2
360 Days3
SecondaryClinical Endpoint: Death

All deaths including cardiac death, vasular death and non-cardiovascular death

Time frame:
30 days, 6 months, 12 months
Reported as:
Count of participants · Participants
Clinical Endpoint: Death
ParticipantsResolute Integrity US Extended Length Sub-Study (RI-US XL)
30 Days0
180 Days0
360 Days1
SecondaryClinical Endpoint: Myocardial Infarction (MI)

All myocardial infarction data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions.

Time frame:
30 days, 6 months, 12 months
Reported as:
Count of participants · Participants
Clinical Endpoint: Myocardial Infarction (MI)
ParticipantsResolute Integrity US Extended Length Sub-Study (RI-US XL)
30 Days2
180 Days2
360 Days4
SecondaryClinical Endpoint: Target Lesion Revascularization (TLR)

Repeat Percutaneous coronary intervention (PCI) or Coronary artery bypass grafting (CABG) to the target lesion.

Time frame:
30 days, 6 months, 12 months
Reported as:
Count of participants · Participants
Clinical Endpoint: Target Lesion Revascularization (TLR)
ParticipantsResolute Integrity US Extended Length Sub-Study (RI-US XL)
30 Days0
180 Days0
360 Days1
SecondaryClinical Endpoint: Target Vessel Revascularization (TVR)

Repeat PCI or CABG of the target vessel.

Time frame:
30 days, 6 months, 12 months
Reported as:
Count of participants · Participants
Clinical Endpoint: Target Vessel Revascularization (TVR)
ParticipantsResolute Integrity US Extended Length Sub-Study (RI-US XL)
30 Days0
180 Days0
360 Days1
SecondaryClinical Endpoint: Stent Thrombosis

All stent thrombosis data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions

Time frame:
Early Thrombosis (<=30 days), Late Thrombosis (31-360 days)
Reported as:
Count of participants · Participants
Clinical Endpoint: Stent Thrombosis
ParticipantsResolute Integrity US Extended Length Sub-Study (RI-US XL)
Early Thrombosis (<=30 days)1
Late Thrombosis (31-360 days)0
SecondaryClinical Endpoint: Stroke

Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.

Time frame:
30 days, 6 months, 12 months
Reported as:
Count of participants · Participants
Clinical Endpoint: Stroke
ParticipantsResolute Integrity US Extended Length Sub-Study (RI-US XL)
30 Days0
180 Days0
360 Days0
SecondaryClinical Endpoint: Bleeding Complications in General

Bleeding complications in general including the GUSTO classification of Severe, Moderate \& Mild will be collected. The GUSTO scale defines clinical events that stratify bleeding episodes into mild, moderate or severe.

Time frame:
30 days, 6 months, 12 months
Reported as:
Count of participants · Participants
Clinical Endpoint: Bleeding Complications in General
ParticipantsResolute Integrity US Extended Length Sub-Study (RI-US XL)
30 Days3
180 Days6
360 Days9
SecondaryDual Antiplatelet Therapy (DAPT) Compliance

Protocol defined DAPT, Aspirin and Clopidogrel or Ticlopidine, at 30 days, 180 day and 360 days.

Time frame:
30 days, 6 months, 12 months
Reported as:
Count of participants · Participants
Dual Antiplatelet Therapy (DAPT) Compliance
ParticipantsResolute Integrity US Extended Length Sub-Study (RI-US XL)
30 Days47
180 Days47
360 Days40

Adverse events

Collected over 1 Year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Resolute Integrity US Extended Length Sub-Study (RI-US XL)1/56 (1.8%)45/56 (80.4%)45/56 (80.4%)
Most frequent serious events
Showing 10 of 35
Most frequent serious events
EventResolute Integrity US Extended Length Sub-Study (RI-US XL)
Angina UnstableCardiac disorders4/56
Acute MICardiac disorders3/56
Coronary Artery DissectionCardiac disorders3/56
Cardiac Failure CongestiveCardiac disorders2/56
Coronary Artery DiseaseCardiac disorders2/56
HypertensionVascular disorders2/56
AnaemiaBlood and lymphatic system disorders1/56
Atrial FibrilationCardiac disorders1/56
Atrial FlutterCardiac disorders1/56
Cardiac FailureCardiac disorders1/56
Most frequent other events
Most frequent other events
EventResolute Integrity US Extended Length Sub-Study (RI-US XL)
Chest PainGeneral disorders11/56
Cardiac Enzymes IncreasedInvestigations8/56
PalpitationsCardiac disorders5/56
BronchitisInfections and infestations5/56
DyspnoeaRespiratory, thoracic and mediastinal disorders5/56
DyspepsiaGastrointestinal disorders4/56
FatigueGeneral disorders4/56
Chronic Obstructive Pulmonary DiseaseRespiratory, thoracic and mediastinal disorders3/56

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Resolute Integrity US Extended Length Sub-Study (RI-US XL)
Mean60.5 ± 10.7
Sex: Female, Male
Sex: Female, Male(Participants)Resolute Integrity US Extended Length Sub-Study (RI-US XL)
Female13
Male43
Region of Enrollment
Region of Enrollment(participants)Resolute Integrity US Extended Length Sub-Study (RI-US XL)
United States56
08

Study locations

1 site
  • St. Joseph's Hospital Health Center
    Syracuse, New York 13203, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01913600
Lead sponsor
Medtronic Vascular
Responsible party
Sponsor
First posted
Aug 1, 2013
Start date
Jul 2013
Primary completion
Oct 2016
Completion
Dec 2018
Results posted
Nov 17, 2017
Last update
May 8, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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