MedTrace Logo

Pilot Clinical Study of MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System

NCT02663323 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2018-08-17

No results posted yet for this study

Summary

MeRes-1 Extend study is designed as prospective, multinational, multicentre, single arm, open label, pilot study to assess the safety and performance of the MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System (BRS) in subjects with de novo native coronary artery lesions. 64 subjects will be enrolled from the 8 centers located in Asia Pacific, Europe, Brazil and South Africa. Primary outcome of study will be Proportion of population reporting Major Adverse Cardiac Events at 6 months from the day of index Procedure.

Conditions

Interventions

DEVICE

MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System

MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System in the treatment of de-novo coronary artery lesions.

Sponsors & Collaborators

  • Meril Life Sciences Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • Dr. Alexandre Abizaid · Dante Pazzanese Hospital, Sao Paulo, Brazil

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-02
Primary Completion
2017-10-05
Completion
2020-07-05

Countries

  • Brazil
  • Indonesia
  • Malaysia
  • North Macedonia

Study Locations

More Related Trials

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 NCT02663323 on ClinicalTrials.gov