Clinical trial NCT03471845: RESOLUTE ONYX China Single Arm Study
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
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)
PERCUTANEOUS CORONARY INTERVENTION (PCI)
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2018-03-21
Enrollment: 591
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

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).

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, 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

Primary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: 12 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 (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
measure: Death (Cardiac and Non-cardiac)
timeFrame: 30 day, 6 months, 9 months (if applicable), 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 (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
measure: All revascularizations
timeFrame: 30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
measure: Target Vessel Failure (TVF)
timeFrame: 30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
measure: Target Lesion Failure (TLF)
timeFrame: 30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
measure: Stent Thrombosis (ST)
timeFrame: 30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
measure: In-stent late luminal loss
timeFrame: 9 months
measure: In-segment late luminal loss
timeFrame: 9 months
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
Other outcomes:
Locations:
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
Study officials:
affiliation: Shanghai Chest Hospital
name: Ben He, MD
role: PRINCIPAL_INVESTIGATOR
References: