First-in-man Trial Examining the Safety and Efficacy of BuMA Supreme and Resolute Integrity in Patients With de Novo Coronary Artery Stenosis
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|ClinicalTrials.gov Identifier: NCT02236975|
Recruitment Status : Completed
First Posted : September 11, 2014
Last Update Posted : July 28, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: BuMA Supreme Biodegradable drug coating coronary stent system Device: Resolute Integrity durable polymer stent system||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||168 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Actual Study Start Date :||April 2015|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||March 2019|
Experimental: BuMA Supreme Biodegradable drug coating coronary stent system
Implant BuMA Supreme stent only
Device: BuMA Supreme Biodegradable drug coating coronary stent system
Active Comparator: Resolute Integrity durable polymer stent system
Implant Resolute stent
Device: Resolute Integrity durable polymer stent system
- Late Lumen Loss [ Time Frame: Up to 9 month ]The primary endpoint is in-stent Late Lumen Loss (LLL) at 9 months after stent implantation as assessed by off-line QCA.
- Angiographic endpoint [ Time Frame: 9 and 12 month ]Acute Lumen Gain (mm);
- Angiographic endpoint [ Time Frame: 9 and 12 month ]MLD (mm) post procedure and at 9 months;
- Angiographic endpoint [ Time Frame: 9 and 12 month ]Diameter Stenosis (%) post procedure and at 9 months;
- Angiographic endpoint [ Time Frame: 9 and 12 month ]Binary Restenosis (DS ≥50%) at 9 months
- Clinical endpoint [ Time Frame: 9 and 12 month ]Acute success (device and procedural success)
- Cinical endpoint [ Time Frame: 9 and 12 month ]Device-oriented Composite Endpoints (DoCE) at 1, 9 and 12 months and its individual components. (Device-oriented Composite Endpoint is defined as Cardiac Death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated Target Lesion Revascularization).
- Clinical endpoint [ Time Frame: 9 and 12 month ]Myocardial infarction (Q-wave, Non q-wave) at all time points.
- Clinical endpoint [ Time Frame: 9 and 12 month ]Any revascularization at all time points.
- Clinical endpoint [ Time Frame: 9 and 12 month ]Stent thrombosis according to the ARC definitions up to 12 months follow-up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236975
|Hospita; Garcia de Orta|
|Santa Maria University Hospital|
|Gaia/Espinho Hospital Centers|
|University Hospital Madrid|
|Hospital Álvaro Cunqueiro|
|Principal Investigator:||Clemens von.Birgelen, MD,Phd||Medisch Spectrum Twente (MST), Enschede, the Netherlands|
|Principal Investigator:||Manel Sabate, MD,Phd||Clinic university hospital Barcelona, Spain|
|Study Chair:||Patrick W.Serruys, MD,Phd||Interventional Cardiology, Thorax center, Erasmus MC, Rotterdam|