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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03466151
Other study ID # MDT16061RES005
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 12, 2018
Est. completion date September 19, 2025

Study information

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

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 550
Est. completion date September 19, 2025
Est. primary completion date February 12, 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, 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


Intervention

Device:
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements
Resolute Integrity™ 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 Fuwai Hospital, Chinese Academy of Medical Science Beijing
China Shengjing Hospital of China Medical University Shenyang Liaoning

Sponsors (1)

Lead Sponsor Collaborator
Medtronic Vascular

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary In-stent Late lumen loss measured by quantitative coronary angiography (QCA) Late lumen loss measured by quantitative coronary angiography (QCA) 9 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, 1 year, 2 years,3 years, 4 years, 5 years
Secondary Death (Cardiac and Non-cardiac) All deaths 30 day, 6 months, 9 months, 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, 1 year, 2 years,3 years, 4 years, 5 years
Secondary 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
Secondary Target Vessel Failure (TVF) TVF 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years
Secondary Target Lesion Failure (TLF) TLF 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years
Secondary Stent Thrombosis (ST) ST 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years
Secondary In-stent and in-segment percent diameter stenosis (%DS) Angiographic measures: In-stent and in-segment percent diameter stenosis (%DS) 9 months
Secondary In-stent and in-segment binary restenosis rate Angiographic measures:In-stent and in-segment binary restenosis rate 9 months
Secondary In-stent and in-segment minimal luminal diameter (MLD) Angiographic measures:In-stent and in-segment minimal luminal diameter (MLD) 9 months
Secondary In-segment late luminal loss Angiographic measures: In-segment late luminal loss 9 months
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