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Study of MeRes100 in the Treatment of Patient With Coronary Artery Disease.

NCT03454724 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 484

Last updated 2019-08-14

No results posted yet for this study

Summary

This is a Multi Center Randomized Control Study of MeRes100 Sirolimus Eluting BioResorbable Vascular Scaffold System in treatment of approximately 484 subjects with Coronary Artery Disease in China. Eligible subjects shall have up to two de novo lesions in different epicardial vessels (One lesion in each coronary artery or it's major branch),Target lesion shall have visually estimated diameter stenosis ≥ 70% (or ≥ 50% and has clinical evidence of myocardial ischemia), lesion length ≤ 24mm, reference vascular diameter visually ≥ 2.75mm and ≤ 4.0mm. And subjects must meet all the study inclusion / exclusion criteria before enrolment in the study.All subjects shall accept clinical follow up at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post procedure.

Conditions

Interventions

DEVICE

MeRes100 Sirolimus-Eluting BioResorbable Vascular Scaffold System

MeRes100 Sirolimus-Eluting BioResorbable Vascular Scaffold System used in the treatment of patients with coronary artery disease along with standard percutaneous angioplasty procedure.

DEVICE

Xience EES Everolimus Eluting Coronary Stent System

Xience EES Everolimus Eluting Coronary Stent System indicated for the treatment of coronary artery disease along with standard percutaneous angioplasty procedure.

Sponsors & Collaborators

  • Meril Life Sciences Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • Gao Runlin, MD · Fuwai Hospital CAMS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2020-12-01
Completion
2024-12-01

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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 NCT03454724 on ClinicalTrials.gov