RESOLUTE ONYX China RCT Study

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 12, 2021

Detailed 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).

Interventions

  • Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
    • Treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements
  • Device: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System
    • Treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements

Arms, Groups and Cohorts

  • Experimental: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
    • Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
  • Active Comparator: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System
    • Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System

Clinical Trial Outcome Measures

Primary Measures

  • In-stent Late lumen loss measured by quantitative coronary angiography (QCA)
    • Time Frame: 9 months
    • Late lumen loss measured by quantitative coronary angiography (QCA)

Secondary Measures

  • Device Success
    • Time Frame: at the end of the index procedure or during hospital stay: estimated 7 days
    • 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.
  • Lesion Success
    • Time Frame: at the end of the index procedure or during hospital stay: estimated 7 days
    • 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.
  • Procedure Success
    • Time Frame: at the end of the index procedure or during hospital stay: estimated 7 days
    • 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.
  • Major Adverse Cardiac Events (MACE)
    • Time Frame: 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years
    • 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
  • Death (Cardiac and Non-cardiac)
    • Time Frame: 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years
    • All deaths
  • Myocardial infarction (all MI, and Target Vessel Myocardial Infarction (TVMI))
    • Time Frame: 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years
    • All myocardial infarction data will be reported per Medtronic historical protocol definitions.
  • All revascularizations
    • Time Frame: 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years
    • Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR
  • Target Vessel Failure (TVF)
    • Time Frame: 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years
    • TVF
  • Target Lesion Failure (TLF)
    • Time Frame: 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years
    • TLF
  • Stent Thrombosis (ST)
    • Time Frame: 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years
    • ST
  • In-stent and in-segment percent diameter stenosis (%DS)
    • Time Frame: 9 months
    • Angiographic measures: In-stent and in-segment percent diameter stenosis (%DS)
  • In-stent and in-segment binary restenosis rate
    • Time Frame: 9 months
    • Angiographic measures:In-stent and in-segment binary restenosis rate
  • In-stent and in-segment minimal luminal diameter (MLD)
    • Time Frame: 9 months
    • Angiographic measures:In-stent and in-segment minimal luminal diameter (MLD)
  • In-segment late luminal loss
    • Time Frame: 9 months
    • Angiographic measures: In-segment late luminal loss

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medtronic Vascular
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yongjian Wu, MD, Principal Investigator, Fuwai Hospital, Chinese Academy of Medical Science

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