RESOLUTE ONYX China RCT Study

N/AActive Not RecruitingNCT03466151

Medtronic Vascular550 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

550

Conditions

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

Interventions

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent SystemDEVICE

Treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements

Resolute Integrity™ Zotarolimus-Eluting Coronary Stent SystemDEVICE

Treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key 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 Key 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

Locations (2)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Fuwai Hospital, Chinese Academy of Medical Science

Beijing, China

Outcomes

Primary Outcomes

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

Late lumen loss measured by quantitative coronary angiography (QCA)

Time frame: 9 months

Secondary Outcomes

Device Success

Definition 1: The attainment of \<50% residual stenosis of the target lesion using only the assigned device. Definition 2: The attainment of \< 30% residual stenosis by QCA (or \< 20% by visual assessment) AND a TIMI flow 3 after the procedure, using the assigned device only. These measurements will be made by the independent angiographic core laboratory.

Time frame: at the end of the index procedure or during hospital stay: estimated 7 days

Lesion Success

Definition 1: The attainment of \<50% residual stenosis of the target lesion using any percutaneous method. Definition 2: The attainment of \< 30% residual stenosis by QCA (or \< 20% by visual assessment) AND a TIMI flow 3 after the procedure, using the assigned device only. These measurements will be made by the independent angiographic core laboratory.

Time frame: at the end of the index procedure or during hospital stay: estimated 7 days

Procedure Success

Definition 1: The attainment of \<50% residual stenosis of the target lesion and no in-hospital MACE. Definition 2: The attainment of \< 30% residual stenosis by QCA (or \< 20% by visual assessment) AND a TIMI flow 3 after the procedure, using the assigned device only. These measurements will be made by the independent angiographic core laboratory.

Time frame: at the end of the index procedure or during hospital stay: estimated 7 days

Major Adverse Cardiac Events (MACE)

Defined as composite of death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods

Data from ClinicalTrials.gov

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