Clinical trial NCT03466151: RESOLUTE ONYX China RCT Study
Official title: 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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ischemic Heart Disease
Stenotic Coronary Lesion
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease
Keywords: Major Adverse Cardiac Events (MACE)
Myocardial Infarction (MI)
Late Lumen Loss (LLL)
Target Lesion Revascularization (TLR)
Target Vessel Revascularization (TVR)
Target Vessel Failure (TVF)
Target Lesion Failure (TLF)
Stent Thrombosis (ST)
The Randomized Controlled Trial
PERCUTANEOUS CORONARY INTERVENTION (PCI)
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2018-03-15
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 Randomization
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: In-stent Late lumen loss measured by quantitative coronary angiography (QCA)
timeFrame: 9 months
Secondary outcomes:
measure: Device Success
timeFrame: at the end of the index procedure or during hospital stay: estimated 7 days
measure: Lesion Success
timeFrame: at the end of the index procedure or during hospital stay: estimated 7 days
measure: Procedure Success
timeFrame: at the end of the index procedure or during hospital stay: estimated 7 days
measure: Major Adverse Cardiac Events (MACE)
timeFrame: 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years
measure: Death (Cardiac and Non-cardiac)
timeFrame: 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years
measure: Myocardial infarction (all MI, and Target Vessel Myocardial Infarction (TVMI))
timeFrame: 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years
measure: All revascularizations
timeFrame: 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years
measure: Target Vessel Failure (TVF)
timeFrame: 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years
measure: Target Lesion Failure (TLF)
timeFrame: 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years
measure: Stent Thrombosis (ST)
timeFrame: 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years
measure: In-stent and in-segment percent diameter stenosis (%DS)
timeFrame: 9 months
measure: In-stent and in-segment binary restenosis rate
timeFrame: 9 months
measure: In-stent and in-segment minimal luminal diameter (MLD)
timeFrame: 9 months
measure: In-segment late luminal loss
timeFrame: 9 months
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Beijing
country: China
facility: Fuwai Hospital, Chinese Academy of Medical Science
Study officials:
affiliation: Fuwai Hospital, Chinese Academy of Medical Science
name: Yongjian Wu, MD
role: PRINCIPAL_INVESTIGATOR
References: