RESOLUTE ONYX China Single Arm Study

N/AActive Not RecruitingNCT03471845

Medtronic Vascular591 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

591

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

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, 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

Locations (1)

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

Outcomes

Primary Outcomes

Target Lesion Failure (TLF)

TLF

Time frame: 12 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 any percutaneous method. These measurements will be made by the independent angiographic core laboratory. If the core laboratory is unable to assess the % residual stenosis, the Investigator's assessment as recorded in the CRF will be used for the statistical analysis.

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 any percutaneous method without the occurrence of MACE during the hospital stay. These measurements will be made by the independent angiographic core laboratory. If the core laboratory is unable to assess the % residual stenosis, the Investigator's assessment as recorded in the CRF will be used for the statistical analysis.

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

Major Adverse Cardiac Events (MACE)

Data from ClinicalTrials.gov

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