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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resolute Integrity Stent
Sponsored by
Medtronic Vascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring TARGET LESION REVASCULARIZATION (TLR), TARGET VESSEL REVASCULARIZATION (TVR), Coronary Artery Disease, MYOCARDIAL INFARCTION (MI), PERCUTANEOUS CORONARY INTERVENTION (PCI), STENT THROMBOSIS, TARGET LESION FAILURE (TLF)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Hospital Health Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Resolute Integrity

Arm Description

Resolute Integrity Stent

Outcomes

Primary Outcome Measures

Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)
The combined clinical outcome of (all cause) mortality, MI or any revascularization

Secondary Outcome Measures

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.
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
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.
Composite Endpoint: Cardiac Death and Target Vessel MI
Combined rate of cardiac death and target vessel MI post-procedure
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.
Clinical Endpoint: Death
All deaths including cardiac death, vasular death and non-cardiovascular death
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.
Clinical Endpoint: Target Lesion Revascularization (TLR)
Repeat Percutaneous coronary intervention (PCI) or Coronary artery bypass grafting (CABG) to the target lesion.
Clinical Endpoint: Target Vessel Revascularization (TVR)
Repeat PCI or CABG of the target vessel.
Clinical Endpoint: Stent Thrombosis
All stent thrombosis data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions
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.
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.
Dual Antiplatelet Therapy (DAPT) Compliance
Protocol defined DAPT, Aspirin and Clopidogrel or Ticlopidine, at 30 days, 180 day and 360 days.

Full Information

First Posted
July 30, 2013
Last Updated
April 24, 2019
Sponsor
Medtronic Vascular
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1. Study Identification

Unique Protocol Identification Number
NCT01913600
Brief Title
Resolute Integrity US Extended Length Sub-Study(RI US XL)
Acronym
RI-US XL
Official Title
Resolute Integrity US A Postapproval Study of the Medtronic Resolute™ Integrity Zotarolimus-Eluting Coronary Stent System in the Treatment of De Novo Lesions in Native Coronary Arteries With a Reference Vessel Diameter of 2.25 mm to 4.2 mm
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 2013 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Vascular

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resolute Integrity
Arm Type
Other
Arm Description
Resolute Integrity Stent
Intervention Type
Device
Intervention Name(s)
Resolute Integrity Stent
Intervention Description
Drug eluting stent (DES)
Primary Outcome Measure Information:
Title
Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)
Description
The combined clinical outcome of (all cause) mortality, MI or any revascularization
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Composite Endpoint: Major Adverse Cardiac Events (MACE)
Description
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
Title
Composite Endpoint: Target Lesion Failure (TLF)
Description
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
Title
Composite Endpoint: Target Vessel Failure (TVF),
Description
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
Title
Composite Endpoint: Cardiac Death and Target Vessel MI
Description
Combined rate of cardiac death and target vessel MI post-procedure
Time Frame
30 days, 6 months, 12 months
Title
Composite Endpoint: Target Vessel MI
Description
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
Title
Clinical Endpoint: Death
Description
All deaths including cardiac death, vasular death and non-cardiovascular death
Time Frame
30 days, 6 months, 12 months
Title
Clinical Endpoint: Myocardial Infarction (MI)
Description
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
Title
Clinical Endpoint: Target Lesion Revascularization (TLR)
Description
Repeat Percutaneous coronary intervention (PCI) or Coronary artery bypass grafting (CABG) to the target lesion.
Time Frame
30 days, 6 months, 12 months
Title
Clinical Endpoint: Target Vessel Revascularization (TVR)
Description
Repeat PCI or CABG of the target vessel.
Time Frame
30 days, 6 months, 12 months
Title
Clinical Endpoint: Stent Thrombosis
Description
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)
Title
Clinical Endpoint: Stroke
Description
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
Title
Clinical Endpoint: Bleeding Complications in General
Description
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
Title
Dual Antiplatelet Therapy (DAPT) Compliance
Description
Protocol defined DAPT, Aspirin and Clopidogrel or Ticlopidine, at 30 days, 180 day and 360 days.
Time Frame
30 days, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
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
Facility Information:
Facility Name
St. Joseph's Hospital Health Center
City
Syracuse
State/Province
New York
ZIP/Postal Code
13203
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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