RESOLUTE ONYX China RCT Study

Not Applicable

Active, not recruiting

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

• Registration Number: NCT03466151
• Lead Sponsor: Medtronic Vascular

Brief Summary

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.

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 Timeline

• Study First Submitted: 2018-03-01
• Study First Submitted QC: 2018-03-08
• Study First Posted: 2018-03-15
• Study Start: 2018-04-12
• Primary Completion: 2021-02-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Study Completion: 2025-09-19

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 550

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
In-stent Late lumen loss measured by quantitative coronary angiography (QCA)	9 months	Late lumen loss measured by quantitative coronary angiography (QCA)

Secondary Outcome Measures

Name	Time	Method
Target Lesion Failure (TLF)	30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years	TLF
In-stent and in-segment percent diameter stenosis (%DS)	9 months	Angiographic measures: In-stent and in-segment percent diameter stenosis (%DS)
Device Success	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.
Stent Thrombosis (ST)	30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years	ST
In-segment late luminal loss	9 months	Angiographic measures: In-segment late luminal loss
Procedure Success	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)	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
All revascularizations	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
Lesion Success	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.
Death (Cardiac and Non-cardiac)	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))	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.
Target Vessel Failure (TVF)	30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years	TVF
In-stent and in-segment binary restenosis rate	9 months	Angiographic measures:In-stent and in-segment binary restenosis rate
In-stent and in-segment minimal luminal diameter (MLD)	9 months	Angiographic measures:In-stent and in-segment minimal luminal diameter (MLD)

Trial Locations

Locations (2)

Shengjing Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China

Fuwai Hospital, Chinese Academy of Medical Science; 🇨🇳 Beijing, China