NCT02236975

First-in-man Trial Examining the Safety and Efficacy of BuMA Supreme and Resolute Integrity in Patients With de Novo Coronary Artery Stenosis

Prospective, Multi-center, Randomized First-in-man Trial Examining the Safety and Efficacy of BuMA Supreme eG (Electro Grafting) Based Biodegradable Polymer Sirolimus-eluting Stent and Resolute Integrity Zotarolimus-eluting Durable Polymer Stent in Patients With de Novo Coronary Artery Stenosis.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Sino Medical Sciences Technology Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, multi-center, randomized 1:1, single blind trial using BuMA Supreme versus Resolute Integrity conducted in approximately 14 interventional cardiology centers in The Netherlands, Belgium, Spain and Portugal. Clinical follow-up will occur at 1, 9 and 12 months post-stent implantation. All patients will undergo repeat angiography at 9 months follow-up. QCA assessment will be performed at baseline (pre- and post-procedure) and at 9 months follow-up.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	BuMA Supreme Biodegradable drug coating coronary stent system
DEVICE	Resolute Integrity durable polymer stent system

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-11-01
• Completion: 2019-03-01
• First posted: 2014-09-11
• Last updated: 2020-07-28

Locations

12 sites across 4 countries: Belgium, Netherlands, Portugal, Spain