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A Study to Evaluate the Efficacy and Safety of BuMA Supreme Drug Eluting Stent(DES)
Sponsor: Sino Medical Sciences Technology Inc.
Summary
PIONEER-II OPC trial is a prospective, multicenter, single-arm registry trial. 1000 subjects from approximately 40 interventional cardiology centers will be enrolled to evaluate the target lesion failure(TLF) as the primary endpoint at 1 year. And all the subjects will be followed up to 5 years to attain the data of the secondary endpoints.
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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2015-12
Completion Date
2025-12
Last Updated
2024-04-25
Healthy Volunteers
No
Conditions
Interventions
BuMA Supreme
Stent platform: cobalt-chromium alloy
Locations (1)
Zhongshan Hospital
Shanghai, China