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An Evaluation of the Commercially Available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System (RI-US)

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Resolute Integrity Stent

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) ≤ 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

Sites / Locations

St. Joseph's Hospital Health Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Resolute Integrity

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Clinical Endpoint: Death

Dual Antiplatelet Therapy (DAPT) Compliance

Clinical Endpoint: TLR

Clinical Endpoint: TVR

Clinical Endpoint: MI

Clinical Endpoint: ST

Clinical Endpoint: Stroke

Clinical Endpoint: Bleeding Complications in General

Full Information

NCT ID

NCT01638507

First Posted

July 9, 2012

Last Updated

March 22, 2019

Sponsor

Medtronic Vascular

1. Study Identification

Unique Protocol Identification Number

NCT01638507

Brief Title

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

Acronym

RI-US

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

March 2019

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Vascular

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

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

230 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Resolute Integrity

Arm Type

Other

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Resolute Integrity Stent

Intervention Description

Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System

Primary Outcome Measure Information:

Title

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

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

Title

Clinical Endpoint: Death

Time Frame

12 months

Title

Dual Antiplatelet Therapy (DAPT) Compliance

Time Frame

12 months

Title

Clinical Endpoint: TLR

Time Frame

12 months

Title

Clinical Endpoint: TVR

Time Frame

12 months

Title

Clinical Endpoint: MI

Time Frame

12 months

Title

Clinical Endpoint: ST

Time Frame

12 months

Title

Clinical Endpoint: Stroke

Time Frame

12 months

Title

Clinical Endpoint: Bleeding Complications in General

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronald Caputo, MD

Organizational Affiliation

Unity Health Toronto

Official's Role

Principal Investigator

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

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

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