A Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in Comparison With the Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Subjects Eligible for Percutaneous Transluminal Coronary Angioplasty (PTCA) in China

Medtronic Vascular3 sites in 1 country550 target enrollmentApril 12, 2018

ConditionsIschemic Heart Disease Stenotic Coronary Lesion Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease

InterventionsResolute Onyx™ Zotarolimus-Eluting Coronary Stent System Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System

Overview

Phase: Not Applicable
Intervention: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Conditions: Ischemic Heart Disease
Sponsor: Medtronic Vascular
Enrollment: 550
Locations: 3
Primary Endpoint: In-stent Late lumen loss measured by quantitative coronary angiography (QCA)
Status: Active, not recruiting
Last Updated: 10 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

It is a randomized controlled trial to evaluate the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in comparison with the Medtronic Resolute Integrity™ Zotarolimus-Eluting coronary stent system in the treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) in China.

Detailed Description

This study is a pre-Market, prospective, multi-center, open-label, randomized controlled trial. Subjects will be 1:1 randomized and followed through 5 Years (screen, implant procedure(including post-procedure assessment),30-Day, 6 Months, 9 Months (primary endpoint\_LLL), and annual assessments from 1-5 years).

Registry

clinicaltrials.gov

Start Date

April 12, 2018

End Date

July 31, 2026

Last Updated

10 days ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medtronic Vascular

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The subject is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, the IB of Resolute Onyx stent, and the IFU of Resolute Integrity stent
•The subject requires treatment of up to 3 target lesions in up to 2 separate target vessels \[2 target lesions in 1 vessel (including its side branches) and 1 target lesion in a separate vessel(including its side branches)\] amenable to treatment with stents with diameter from 2.25 mm to 4.0 mm

Exclusion Criteria

•Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, P2Y12 inhibitors, mTOR inhibiting drugs such as zotarolimus, Biolimus A9 (or its derivatives), cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated
•PCI of the target vessel within 9 months prior to the procedure
•Active bleeding
•Subjects with a life expectancy of less than 12 months
•Participation in another clinical study
•Pregnant, or lactating women

Arms & Interventions

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Intervention: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System

Intervention: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System

Outcomes

Primary Outcomes

In-stent Late lumen loss measured by quantitative coronary angiography (QCA)

Time Frame: 9 months

Late lumen loss measured by quantitative coronary angiography (QCA)

Secondary Outcomes

Target Lesion Failure (TLF)(30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years)
In-stent and in-segment percent diameter stenosis (%DS)(9 months)
Device Success(at the end of the index procedure or during hospital stay: estimated 7 days)
Stent Thrombosis (ST)(30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years)
In-segment late luminal loss(9 months)
Procedure Success(at the end of the index procedure or during hospital stay: estimated 7 days)
Major Adverse Cardiac Events (MACE)(30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years)
All revascularizations(30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years)
Lesion Success(at the end of the index procedure or during hospital stay: estimated 7 days)
Death (Cardiac and Non-cardiac)(30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years)
Myocardial infarction (all MI, and Target Vessel Myocardial Infarction (TVMI))(30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years)
Target Vessel Failure (TVF)(30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years)
In-stent and in-segment binary restenosis rate(9 months)
In-stent and in-segment minimal luminal diameter (MLD)(9 months)