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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Cardiac Stent
Composite Endpoint
MACE (Hierarchical incidence of Cardiovascular Death, Myocardial infarction or Target Vessel Revascularization)
Time frame: 1 Year
Incidence of DOCE
1. Cardiovascular Death 2. Myocardial infarction in the territory of Target vessel 3. Clinically driven target lesion revascularization
Time frame: 30 Days, 180 Days, 270 Days and 360 days
Incidence of POCE
1. All cause death 2. Any Stroke 3. Any myocardial infarction 4. Any revascularization
Time frame: 30 Days, 180 Days, 270 Days and 360 days
Incidence of MACE
1. Cardiovascular Death 2. Non-fatal MI 3. Target Vessel Revascularization
Time frame: 30 Days, 180 Days and 360 days
Target vessel failure (TVF)
Target vessel failure (TVF)
Time frame: 30 Days, 180 Days, 270 Days and 360 days
Non-Target Vessel related Myocardial Infarction
Non-Target Vessel related Myocardial Infarction
Time frame: 30 Days, 180 Days, 270 Days and 360 days
Stent thrombosis
Stent thrombosis as per 1. Academic Research Consortium \[ARC\] Evidence definitions - Definite and probable 2. As per latency - Acute (0-24 hours), Subacute (24 hours-30 days) and late (30-365 days)
Time frame: 0-24 hours, 24 hours-30 days and late 30-365 days
Device success
* Residual coronary stenosis less than 20% * Normal coronary flow and absence of coronary dissections \> C * Procedural and absence of PCI complications including periprocedural MI, coronary perforation, urgent CABG or death or revascularization within 3 days of Index procedure
Time frame: 0 hour, 24 hours, 3 days
Procedural Success
* Residual Stenosis less than 20% * Successful reperfusion of Target vessel region with TIMI Flow ≥ 2
Time frame: 24 Hours
Acute Device Success
Acute Device Success as defined by Residual Stenosis ≤ 20%
Time frame: 24 Hours
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