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Clinical Trial 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT06300268
Study type Interventional
Source Advanced MedTech Solutions Pvt. Ltd.
Contact Dr Jayesh Jani
Phone 8130009876
Email jjani@amsltd.com
Status Not yet recruiting
Phase N/A
Start date June 2024
Completion date December 2026

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