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Advapro Coronary Stent System in Coronary Artery Diseased Patients.

NCT06300268 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-03-08

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

AdvaPro Sirolimus Eluting Coronary Stent System

Cardiac Stent

Sponsors & Collaborators

  • Advanced MedTech Solutions Pvt. Ltd.

    lead OTHER

Principal Investigators

  • Dr Philippe Garot · Hôpital Privé Jacques Cartier, Massy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-30
Primary Completion
2026-06-30
Completion
2026-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06300268 on ClinicalTrials.gov