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CompletedNCT01638507RI-USUpdated Apr 3, 2019Results posted

An Evaluation of the Commercially Available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System

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 2019-04-03.

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

Phase
Not applicable
Study type
Interventional
Enrollment
230
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this post approval study is to conduct a prospective, multicenter evaluation of the procedural and clinical outcomes of subjects that are treated with the commercially available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System.

Read the detailed description

The purpose and objective is 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(RD) of 2.25mm to 4.2mm in two groups of patients, specifically those patients receiving stents less than or equal to 30mm in length.

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

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 230 is above the median of 124 across 3,436 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) ≤ 27 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 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
230 participants (actual)

Study arms

  • Other
    Resolute Integrity

    Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity Stent)

    Device: Resolute Integrity Stent

Interventions

  • DeviceResolute Integrity Stent

    Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System

06

What researchers measure

Primary outcomes

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

    Time frame: 12 months

Secondary outcomes

  1. Composite Endpoints: Major Adverse Cardiac Events (MACE), Target Lesion Failure (TLF), Target Vessel Failure (TVF), Cardiac Death and Target Vessel MI

    Time frame: 12 months

  2. Clinical Endpoint: Death

    Time frame: 12 months

  3. Dual Antiplatelet Therapy (DAPT) Compliance

    Time frame: 12 months

  4. Clinical Endpoint: TLR

    Time frame: 12 months

  5. Clinical Endpoint: TVR

    Time frame: 12 months

  6. Clinical Endpoint: MI

    Time frame: 12 months

  7. Clinical Endpoint: ST

    Time frame: 12 months

  8. Clinical Endpoint: Stroke

    Time frame: 12 months

  9. Clinical Endpoint: Bleeding Complications in General

    Time frame: 12 months

07

Results

Posted Nov 25, 2015

Participant flow

230 PEG subjects were enrolled from 29 study sites in the United States. The first subject was enrolled on July 23, 2012 and the last subject was enrolled on May 31, 2013.

Participant flow — Overall Study
MilestonePrimary Enrollment Group (PEG)
Started230
Completed224
Not completed6

Outcome measures

PrimaryComposite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)
Time frame:
12 months
Reported as:
Number · percentage of participants
Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)
percentage of participantsPrimary Enrollment Group (PEG)
Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)3.6 (1.6 to 7.0)
SecondaryComposite Endpoints: Major Adverse Cardiac Events (MACE), Target Lesion Failure (TLF), Target Vessel Failure (TVF), Cardiac Death and Target Vessel MI
Time frame:
12 months
Reported as:
Number · percentage of composite
Composite Endpoints: Major Adverse Cardiac Events (MACE), Target Lesion Failure (TLF), Target Vessel Failure (TVF), Cardiac Death and Target Vessel MI
percentage of compositePrimary Enrollment Group (PEG)
Composite Endpoints: Major Adverse Cardiac Events (MACE), Target Lesion Failure (TLF), Target Vessel Failure (TVF), Cardiac Death and Target Vessel MI15.0
SecondaryClinical Endpoint: Death
Time frame:
12 months
Reported as:
Number · percentage of death
Clinical Endpoint: Death
percentage of deathPrimary Enrollment Group (PEG)
Clinical Endpoint: Death1.8
SecondaryDual Antiplatelet Therapy (DAPT) Compliance
Time frame:
12 months
Reported as:
Number · percentage of compliance
Dual Antiplatelet Therapy (DAPT) Compliance
percentage of compliancePrimary Enrollment Group (PEG)
Dual Antiplatelet Therapy (DAPT) Compliance89.2
SecondaryClinical Endpoint: TLR
Time frame:
12 months
Reported as:
Number · percentage of TLR
Clinical Endpoint: TLR
percentage of TLRPrimary Enrollment Group (PEG)
Clinical Endpoint: TLR2.3
SecondaryClinical Endpoint: TVR
Time frame:
12 months
Reported as:
Number · percentage of TVR
Clinical Endpoint: TVR
percentage of TVRPrimary Enrollment Group (PEG)
Clinical Endpoint: TVR4.5
SecondaryClinical Endpoint: MI
Time frame:
12 months
Reported as:
Number · percentage of MIs
Clinical Endpoint: MI
percentage of MIsPrimary Enrollment Group (PEG)
Clinical Endpoint: MI2.7
SecondaryClinical Endpoint: ST
Time frame:
12 months
Reported as:
Number · percentage of ST
Clinical Endpoint: ST
percentage of STPrimary Enrollment Group (PEG)
Clinical Endpoint: ST0.9
SecondaryClinical Endpoint: Stroke
Time frame:
12 months
Reported as:
Number · percentage of strokes
Clinical Endpoint: Stroke
percentage of strokesPrimary Enrollment Group (PEG)
Clinical Endpoint: Stroke0.5
SecondaryClinical Endpoint: Bleeding Complications in General
Time frame:
12 months
Reported as:
Number · percentage of bleeding complications
Clinical Endpoint: Bleeding Complications in General
percentage of bleeding complicationsPrimary Enrollment Group (PEG)
Clinical Endpoint: Bleeding Complications in General11.4

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Primary Enrollment Group (PEG)—88/230 (38.3%)51/230 (22.2%)
Most frequent serious events
Showing 10 of 78
Most frequent serious events
EventPrimary Enrollment Group (PEG)
Chest PainGeneral disorders17/230
Angina PectorisCardiac disorders7/230
Coronary Artery DiseaseCardiac disorders7/230
Coronary Artery DissectionCardiac disorders7/230
Myocardial InfarctionCardiac disorders5/230
Angina UnstableCardiac disorders4/230
Non-Cardiac Chest PainGeneral disorders4/230
PneumoniaInfections and infestations4/230
Acute Myocardial InfarctionCardiac disorders3/230
Atrial FibrillationCardiac disorders3/230
Most frequent other events
Most frequent other events
EventPrimary Enrollment Group (PEG)
Chest PainGeneral disorders24/230
Cardiac Enzymes IncreasedInvestigations14/230
Angina PectorisCardiac disorders13/230

Baseline characteristics

Age, Continuous
Age, Continuous(years)Primary Enrollment Group (PEG)
Mean64.4 ± 10.5
Sex: Female, Male
Sex: Female, Male(Participants)Primary Enrollment Group (PEG)
Female70
Male160
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 Apr 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01638507
Lead sponsor
Medtronic Vascular
Responsible party
Sponsor
First posted
Jul 11, 2012
Start date
Jul 2012
Primary completion
Jun 2014
Completion
Jun 2015
Results posted
Nov 25, 2015
Last update
Apr 3, 2019

Study contacts

Ronald Caputo, MD
principal investigator · Unity Health Toronto

Oversight

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

Not currently enrolling

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

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