RESOLUTE ONYX China RCT Study

Medtronic

Status: Active, not recruiting

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

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03466151

MDT16061RES005

Details and patient eligibility

About

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.

Full 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).

Enrollment: 550 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, 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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550 participants in 2 patient groups

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

Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System

Active Comparator group

Description:

Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System

Treatment:

Device: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System