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

NCT ID: NCT01638507

Last Updated: 2019-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2015-06-30

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Resolute Integrity

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

Group Type: OTHER

Resolute Integrity Stent

Intervention Type: DEVICE

Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System

Interventions

Resolute Integrity Stent

Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Vascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald Caputo, MD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

St. Joseph's Hospital Health Center

Syracuse, New York, United States

Countries

United States

Other Identifiers

IP 126

Identifier Type: -

Identifier Source: org_study_id