The Medtronic RESOLUTE US Clinical Trial

Overview

The objective of the study is to assess the safety and effectiveness of the Resolute Zotarolimus-Eluting Coronary Stent System 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.

Full Title of Study: “A Clinical Evaluation of the Medtronic Resolute 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 4.2mm”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2011

Detailed Description

The trial is comprised of four studies: the 2.25 mm – 3.5 mm main study (1242 patients), the 2.25 mm – 3.5 mm Angio/IVUS sub-study (100 patients), the 4.0 mm sub-study (60 patients), and the 38 mm Length Sub-study (114 patients). A patient's inclusion in a given study is dependent on the size (diameter or length) of the stent(s) the patient receives.

Interventions

  • Device: Resolute Zotarolimus-Eluting Coronary Stent
    • Implantation of a Resolute Zotarolimus-Eluting Coronary Stent

Arms, Groups and Cohorts

  • Experimental: Resolute Zotarolimus-Eluting Coronary Stent
    • Implantation of a Resolute Zotarolimus-Eluting Coronary Stent

Clinical Trial Outcome Measures

Primary Measures

  • Target Lesion Failure (TLF)
    • Time Frame: 12 Months
    • Target Lesion Failure (TLF) at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (TVMI) (Q wave and non-Q wave) or clinically-driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods.

Secondary Measures

  • Target Vessel Failure (TVF)
    • Time Frame: 12 months
    • Target Vessel Failure (TVF) composite endpoint and each individual component (Cardiac Death, Target Vessel MI, or clinically-driven Target Vessel Revascularization (TVR) by percutaneous or surgical methods).
  • Major Adverse Cardiac Event (MACE)
    • Time Frame: 12 months
    • Major Adverse Cardiac Event (MACE) composite endpoint and each individual component (death, Target Vessel MI (Q wave and non-Q wave), emergent coronary bypass surgery (CABG), or clinically-driven repeat Target Lesion Revascularization (TLR) by percutaneous or surgical methods).
  • Death
    • Time Frame: 12 months
  • Target Vessel MI
    • Time Frame: 12 months
    • Target Vessel MI (as determined by extended historical and ARC definitions).
  • Stent Thrombosis (ST)
    • Time Frame: 12 months
    • Stent Thrombosis (ST) (as determined by historic and ARC definitions).

Participating in This Clinical Trial

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 at same investigational site – 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 (or ≤ 35 mm for a lesion to be treated with a 38 mm length stent) – Target vessel(s) have reference vessel diameter 2.25 mm to 4.2 mm, (or 3.0 to 4.2 mm for it to be treated with a 38 mm length stent) General and Angiographic Exclusion Criteria highlights: – Within 7 days of implant platelet count <100,000 cells/mm³ or >700,000 cells/mm³; WBC count <3,000 cells/mm³; serum creatinine level >2.5 mg/dl – Acute MI within 72 hrs of the index procedure (QWMI or any elevation of 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 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medtronic Vascular
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Martin B Leon, MD, Principal Investigator, Columbia University College of Physicians & Surgeons
    • Laura Mauri, MD, MSc, Principal Investigator, Brigham and Women’s Hospital
    • Alex C Yeung, MD, Principal Investigator, Stanford University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.