NCT03454724

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

A Multi Center Randomized Control Study of MeRes100 Sirolimus Eluting BioResorbable Vascular Scaffold System in Treatment of Coronary Artery Disease Patients: MeRes - China.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 484 (estimated)
• Sponsor: Meril Life Sciences Pvt. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Multi Center Randomized (MeRes:XIENCE=1:1) Control Study of MeRes100 Sirolimus Eluting BioResorbable Vascular Scaffold System in treatment of approximately 484 subjects with Coronary Artery Disease in China. The post marketed XIENCE Everolimus Eluting Coronary Stent System will serve as the control device, to evaluate the safety and efficacy of MeRes100 Sirolimus Eluting BioResorbable Vascular Scaffold System in coronary artery disease, and to support the product registration approval of the China Food and Drug Administration (CFDA). 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 the subjects shall accept angiography follow up at 12 months post procedure. OCT subgroup ((N=80, 40 from test group and 40 from control group) shall accept follow up of OCT at immediately and 12 months post procedure. In segment late lumen loss at 12 months post procedure is the primary endpoint, and the percentage of stent strut neointimal coverage assessed with OCT at 12 months post procedure is the key secondary endpoint.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-01-01
• Primary completion: 2020-12-01
• Completion: 2024-12-01
• First posted: 2018-03-06
• Last updated: 2019-08-14