Arteriosclerosis, Cardiovascular Diseases, Coronary Artery Disease, Ischemic Heart Disease, Stenotic Coronary Lesion
Conditions
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)
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).
Interventions
Treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements
Sponsors
Medtronic Vascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Group Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Failure (TLF) | 12 months | TLF |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 any percutaneous method. These measurements will be made by the independent angiographic core laboratory. If the core laboratory is unable to assess the % residual stenosis, the Investigator's assessment as recorded in the CRF will be used for the statistical analysis. |
| 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 any percutaneous method without the occurrence of MACE during the hospital stay. These measurements will be made by the independent angiographic core laboratory. If the core laboratory is unable to assess the % residual stenosis, the Investigator's assessment as recorded in the CRF will be used for the statistical analysis. |
| 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), 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) |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORBen He, MD
Shanghai Chest Hospital
Outcome results
None listed