RESOLUTE ONYX China Single Arm Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System |
Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements
|
Outcome Measures
Primary Outcome Measures
- Target Lesion Failure (TLF) [12 months]
TLF
Secondary Outcome Measures
- 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 the assigned device only. These measurements will be made by the independent angiographic core laboratory.
- 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 the assigned device only. These measurements will be made by the independent angiographic core laboratory.
- 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), emergent coronary bypass surgery, 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)
Eligibility Criteria
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.
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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
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PCI of the target vessel within 9 months prior to the procedure
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Active bleeding
-
Subjects with a life expectancy of less than 12 months
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Participation in another clinical study
-
Pregnant, or lactating women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | China |
Sponsors and Collaborators
- Medtronic Vascular
Investigators
- Principal Investigator: Ben He, MD, Shanghai Chest Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MDT16058RES004