RESOLUTE ONYX China Single Arm Study

Medtronic

Status: Active, not recruiting

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

Treatments: Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03471845

MDT16058RES004

Details and patient eligibility

About

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.

Full 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).

Enrollment: 591 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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, 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

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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591 participants in 1 patient group

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Experimental group

Description:

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Treatment:

Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System