A Prospective, MulticentRe, Pilot Study to Evaluate the Safety and Performance of The AdvaPro Sirolimus Eluting CorOnary Stent System in Coronary ARtery Stenosis in Indian and European Population(RESTORE)
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Advanced MedTech Solutions Pvt. Ltd.
- Enrollment
- 120
- Primary Endpoint
- Composite Endpoint
Overview
Brief Summary
A Prospective, Multicentre, Pilot Study to Evaluate the Safety and Performance of the AdvaPro Sirolimus Eluting Coronary Stent System in Coronary Artery Stenosis in Indian and European Population.
To evaluate the performance of AdvaPro Sirolimus Eluting Stent follow up indicated by MACE at 9 months.
Of the 120, 40 patients will be assigned to European population and 80 patients will be assigned to Indian population. QCA is applicable for only in sub-strategy participants at baseline and 9 month follow-up visit.
A QCA Analysis will be performed on minimum 48 patients in Indian population only.
Interval(Days) for patients visit at Day 0, Day 30±6, Day 180±8, Day 270±10 and Day 360±14.
Detailed Description
A Prospective, Multicentre, Pilot Study to Evaluate the Safety and Performance of the AdvaPro Sirolimus Eluting Coronary Stent System in Coronary Artery Stenosis in Indian and European Population(RESTORE).
A QCA Analysis will be performed on minimum 48 patients in Indian population only at baseline visit and 9 month follow-up.
Interval(Days) for patients visit at Day 0, Day 30±7, Day 180±8, Day 270±10 and Day 360±14.
Sample size distribution:
Of the 120, 40 patients will be assigned to European population and 80 patients will be assigned to Indian population.
Primary Objective:
To evaluate the performance of AdvaPro Sirolimus Eluting Stent follow up indicated by MACE at 9 months.
Secondary Objectives:
To estimate patient safety and performance through incidence of Major Adverse Cardiac Events (MACE) at 30, 180, 360 days and device oriented composite end point (DOCE), patient oriented composite end point (POCE) Stent Thrombosis, Target vessel failure (TVF), Target Vessel related Myocardial Infarction (TV-MI), and individual components of composite end points at 30, 180, 270 and 360 days after use of AdvaPro Sirolimus Eluting Stent.
To estimate device and procedure success at 30, 180, 270 and 360 days after use of AdvaPro Sirolimus Eluting Stent.
To Estimate Definitive parameters of performance of AdvaPro Sirolimus Eluting Stent as defined by Late Lumen Loss and Diameter Stenosis percentage at 270 days of AdvaPro Sirolimus Eluting Stent.
Exploratory objectives: None
Stent is approved for manufacturing and marketing in India.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age \>18 years
- •Gender : All (Males, Females, Transgenders, Non-binary)
- •ICF : Patient or legally authorized representative (LAR) agrees to participation by signing the informed consent form.
- •Condition - Clinical : Patient with coronary artery disease Eligible for percutaneous coronary intervention (PCI)
- •Condition - Angiographic : Patient with coronary artery disease having one or more de novo stenosis lesion in two native coronary artery with a visually estimated diameter stenosis ≥70%
- •Condition - Angiographic : Patients with Reference vessel diameter of 2.5 \~ 3.50 mm
- •Condition - Angiographic : Patients with lesion length ≤ 36 mm
Exclusion Criteria
- •Ethical : Pregnant and lactating females
- •Patients requiring staged procedure
- •Condition : Known congestive heart failure (NYHA IV) or left ventricular ejection fraction (LVEF) \<30%
- •Condition : Patients with known hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, Sirolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media
- •Condition : Current medical condition with a life expectancy of less than 12 months
- •Condition : Diagnosis: Acute Myocardial Infarction within 72 hours of Planned Index procedure
- •Condition : Patient has current unstable arrhythmias
- •Procedural : Patients previously treated with PCI or CABG for any coronary artery lesion revascularization
- •Procedural : Patients with Chronic Total Occlusion in two or more vessels
- •Procedural : Patients with Ostial lesions (within 5.0mm of vessel origin).
Outcomes
Primary Outcomes
Composite Endpoint
Time Frame: 1 Year
MACE (Hierarchical incidence of Cardiovascular Death, Myocardial infarction or Target Vessel Revascularization)
Secondary Outcomes
- Incidence of MACE(30 Days, 180 Days and 360 days)
- Stent thrombosis(0-24 hours, 24 hours-30 days and late 30-365 days)
- Incidence of POCE(30 Days, 180 Days, 270 Days and 360 days)
- Procedural Success(24 Hours)
- Acute Device Success(24 Hours)
- Device success(0 hour, 24 hours, 3 days)
- Non-Target Vessel related Myocardial Infarction(30 Days, 180 Days, 270 Days and 360 days)
- Incidence of DOCE(30 Days, 180 Days, 270 Days and 360 days)
- Target vessel failure (TVF)(30 Days, 180 Days, 270 Days and 360 days)