RESOLUTE ONYX China RCT 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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Coronary Artery Disease; Arteriosclerosis; Ischemic Heart Disease; Stenotic Coronary Lesion
• Intervention / Treatment: Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System; Device: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System

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).

• Study Type: Interventional
• Enrollment (Actual): 550
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100037
    • Fuwai Hospital, Chinese Academy of Medical Science
  • Liaoning
    • Shenyang, Liaoning, China
      • ShengJing Hospital Of China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System	Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System; Treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements
Active Comparator: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System	Device: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System; Treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-stent Late lumen loss measured by quantitative coronary angiography (QCA)	Late lumen loss measured by quantitative coronary angiography (QCA)	9 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medtronic Vascular
• Investigators: Principal Investigator: Yongjian Wu, MD, Fuwai Hospital, Chinese Academy of Medical Science

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2018
• Primary Completion (Actual): February 12, 2021
• Study Completion (Estimated): September 19, 2025

Study Registration Dates

• First Submitted: March 1, 2018
• First Submitted That Met QC Criteria: March 8, 2018
• First Posted (Actual): March 15, 2018

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Target Vessel Revascularization (TVR); Target Lesion Revascularization (TLR); Myocardial Infarction (MI); Target Vessel Failure (TVF); Target Lesion Failure (TLF); Major Adverse Cardiac Events (MACE); Late Lumen Loss (LLL); Stent Thrombosis (ST); The Randomized Controlled Trial; PERCUTANEOUS CORONARY INTERVENTION (PCI)
• Additional Relevant MeSH Terms: Vascular Diseases; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: MDT16061RES005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No