A Study to Evaluate the Efficacy and Safety of BuMA Supreme Drug Eluting Stent(DES) (OPC)
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|ClinicalTrials.gov Identifier: NCT02698852|
Recruitment Status : Active, not recruiting
First Posted : March 4, 2016
Last Update Posted : May 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: BuMA Supreme||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Multicenter Trial Program in China to Evaluate the Efficacy and Safety of BuMA Supreme (eG Grafting) Biodegradable Polymer Sirolimus Eluting Stent in Patients With de Novo Coronary Lesions, OPC Trial|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||December 2023|
Experimental: BuMA Supreme group
Totally 1000 subjects combined the 220 subjects from randomized controlled trial(RCT) group
Device: BuMA Supreme
Stent platform: cobalt-chromium alloy
- Target Lesion Failure [ Time Frame: 1 year ]Target Lesion Failure(TLF) is defined as cardiac death, target vessel myocardial infarction(MI), or clinically-driven target lesion revascularization (TLR).
- Stent implantation success rate [ Time Frame: 5 years after PCI ]The stent implantation success rate includes device, lesion and clinical success rate.
- Device-oriented Composite Endpoint(DoCE) [ Time Frame: 1, 6, 12 month, and annually up to 5 years post procedure ]Device-oriented Composite Endpoint is defined as cardiac death, target vessel MI, or clinically-driven TLR (TLF).
- Patient-oriented Composite Endpoint (PoCE) [ Time Frame: 1, 6, 12 month, and annually up to 5 years post procedure ]Patient-oriented Composite Endpoint is defined as all cause death, all MI, or any revascularization.
- Academic Research Consortium(ARC) defined stent thrombosis [ Time Frame: 5 years after PCI ]Definite and probable stent thrombosis during acute, subacute, later and very late phase.
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): NCT02698852
|Shanghai, China, 200032|
|Principal Investigator:||Junbo Ge, Ph.D.||Shanghai Zhongshan Hospital|
|Principal Investigator:||Yundai Chen, Ph.D.||The General Hospital of PLA (301 hospital)|
|Principal Investigator:||Shaoping Nie, Ph.D.||Bejing Anzhen Hospital|
|Principal Investigator:||Shubin Qiao, Ph.D.||Fu Wai Hospital|
|Principal Investigator:||Yawei Xu, Ph.D.||Shanghai 10th People's Hospital|
|Principal Investigator:||Bo Yu, Ph.D.||The 2th Affiliated Hospital of Harbin Medical University|