NCT02663323

Pilot Clinical Study of MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System

MeRes-1 Extend: A Prospective, Multinational, Multicenter, Single Arm, Open Label, Pilot Clinical Study of MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System in the Treatment of De-novo Native Coronary Artery Lesions

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Meril Life Sciences Pvt. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Coronary Artery Disease

Interventions

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

Timeline

• Start date: 2016-02-02
• Primary completion: 2017-10-05
• Completion: 2020-07-05
• First posted: 2016-01-26
• Last updated: 2018-08-17

Locations

4 sites across 4 countries: Brazil, Indonesia, Malaysia, North Macedonia