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

Coronary Artery Disease Clinical Trial

Official title:
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.

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02236975
Study type Interventional
Source Sino Medical Sciences Technology Inc.
Contact
Status Completed
Phase Phase 2/Phase 3
Start date April 2015
Completion date March 2019
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