RESOLUTE JAPAN SVS: The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent in the Treatment of De Novo Lesions in Small Diameter Native Coronary Arteries

Medtronic Vascular1 site in 1 country65 target enrollmentJune 2010

ConditionsArterial Occlusive Diseases Myocardial Ischemia Cardiovascular Diseases Coronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Arterial Occlusive Diseases
Sponsor: Medtronic Vascular
Enrollment: 65
Locations: 1
Primary Endpoint: Target Lesion Failure(TLF)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of the study is To verify the safety and efficacy of the MDT-4107 Drug-Eluting Coronary Stent in the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) that allows the use of 2.25mm diameter stents.

Detailed Description

The objective of the study is to verify the safety and efficacy of the MDT-4107 Drug-Eluting Coronary Stent in the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) that allows the use of 2.25mm diameter stents.

Registry

clinicaltrials.gov

Start Date

June 2010

End Date

June 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medtronic Vascular

Responsible Party

Sponsor

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 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
•Target vessel(s) have reference vessel diameter 2.25 mm to 3.5 mm

Exclusion Criteria

•Within 7 days of implant 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 index procedure (Q wave myocardial infarction(QWMI)/non Q wave myocardial infarction (NQMI) or any elevation of creatinine kinease myocardial-band isoenzyme(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

Outcomes

Primary Outcomes

Target Lesion Failure(TLF)

Time Frame: 9 month

Target Lesion Failure (TLF) at 9 months post-procedure defined as a composite measure of cardiac death, heart attack attributed to the target vessel (target vessel myocardial infarction), and ischemia-driven target lesion revascularization (TLR)