RESOLUTE ONYX China Single Arm Study

Not Applicable

Active, not recruiting

• Conditions: Coronary Artery Disease; Stenotic Coronary Lesion; Cardiovascular Diseases; Ischemic Heart Disease; Arteriosclerosis
• Interventions: Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

• Registration Number: NCT03471845
• Lead Sponsor: Medtronic Vascular

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2018-03-01
• Study First Submitted QC: 2018-03-19
• Study First Posted: 2018-03-21
• Study Start: 2018-03-30
• Primary Completion: 2021-02-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-16
• Study Completion: 2025-10-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 591

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System	Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System	Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Primary Outcome Measures

Name	Time	Method
Target Lesion Failure (TLF)	12 months	TLF

Secondary Outcome Measures

Name	Time	Method
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.
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 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.
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 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.
Major Adverse Cardiac Events (MACE)	30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years	Defined as composite of death, myocardial infarction (Q wave and non-Q wave), or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods
Death (Cardiac and Non-cardiac)	30 day, 6 months, 9 months (if applicable), 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 (if applicable), 1 year, 2 years,3 years, 4 years, 5 years	All myocardial infarction data will be reported per Medtronic historical protocol definitions.
All revascularizations	30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years	Combined endpoints including Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR
Target Vessel Failure (TVF)	30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years	TVF
Target Lesion Failure (TLF)	30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years	TLF
Stent Thrombosis (ST)	30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years	ST
In-stent late luminal loss	9 months	Only for subjects implanted with certain stent sizes: Angiographic measures: In-stent and In-segment late luminal loss
In-segment late luminal loss	9 months	Only for subjects implanted with certain stent sizes: Angiographic measures: In-stent and In-segment late luminal loss
In-stent and in-segment percent diameter stenosis (%DS)	9 months	Only for subjects implanted with certain stent sizes: Angiographic measures: In-stent and in-segment percent diameter stenosis (%DS)
In-stent and in-segment binary restenosis rate	9 months	Only for subjects implanted with certain stent sizes: Angiographic measures: In-stent and in-segment binary restenosis rate
In-stent and in-segment minimal luminal diameter (MLD)	9 months	Only for subjects implanted with certain stent sizes: Angiographic measures:In-stent and in-segment minimal luminal diameter (MLD)

Trial Locations

Locations (1)

Affiliated Hospital of Jiangsu University; 🇨🇳 Zhenjiang, Jiangsu, China