RESOLUTE ONYX China Single Arm Study

Coronary Artery Disease Clinical Trial

Official title:

A Single Arm Clinical Evaluation of Safety and Efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Subjects Eligible for Percutaneous Transluminal Coronary Angioplasty (PTCA) in China

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03471845
• Other study ID #: MDT16058RES004
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 30, 2018
• Est. completion date: October 2, 2025

Study information

• Verified date: April 2024
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 591
• Est. completion date: October 2, 2025
• Est. primary completion date: February 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriosclerosis
• Cardiovascular Diseases
• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia
• Stenotic Coronary Lesion

Intervention

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

Locations

Country	Name	City	State
China	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Lesion Failure (TLF)	TLF	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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 (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
Secondary	Death (Cardiac and Non-cardiac)	All deaths	30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
Secondary	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 (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
Secondary	All revascularizations	Combined endpoints including Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR	30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
Secondary	Target Vessel Failure (TVF)	TVF	30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
Secondary	Target Lesion Failure (TLF)	TLF	30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
Secondary	Stent Thrombosis (ST)	ST	30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
Secondary	In-stent late luminal loss	Only for subjects implanted with certain stent sizes: Angiographic measures: In-stent and In-segment late luminal loss	9 months
Secondary	In-segment late luminal loss	Only for subjects implanted with certain stent sizes: Angiographic measures: In-stent and In-segment late luminal loss	9 months
Secondary	In-stent and in-segment percent diameter stenosis (%DS)	Only for subjects implanted with certain stent sizes: Angiographic measures: In-stent and in-segment percent diameter stenosis (%DS)	9 months
Secondary	In-stent and in-segment binary restenosis rate	Only for subjects implanted with certain stent sizes: Angiographic measures: In-stent and in-segment binary restenosis rate	9 months
Secondary	In-stent and in-segment minimal luminal diameter (MLD)	Only for subjects implanted with certain stent sizes: Angiographic measures:In-stent and in-segment minimal luminal diameter (MLD)	9 months