RESOLUTE ONYX China Single Arm Study

NCT ID: NCT03471845

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 591 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-30
• Study Completion Date: 2026-04-30

Brief Summary

It is a single arm clinical evaluation of safety and efficacy of the Medtronic Resolute Onyx™ zotarolimus-eluting coronary stent system in subjects who are eligible for percutaneous transluminal coronary angioplasty (PTCA) in de novo lesions amenable to treatment with Resolute Onyx™ Stent System in China.

Detailed Description

This study is a pre-Market, prospective, multi-center, single arm trial. Subjects will be enrolled and followed through 5 Years (screen, implant procedure(including post-procedure assessment),30-Day, 6 Months, 9 Months-subjects implanted with fringe size, and annual assessments from 1-5 years).

Conditions

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

Study Design

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

Study Groups

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Group Type: EXPERIMENTAL

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Intervention Type: DEVICE

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

Interventions

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

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

Intervention Type: DEVICE

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, and the IB of Resolute Onyx 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 5.0 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

• 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

Ben He, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Chest Hospital

Locations

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

Countries

China

Other Identifiers

MDT16058RES004

Identifier Type: -

Identifier Source: org_study_id