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ACTIVE NOT RECRUITING
NCT02698852
NA

A Study to Evaluate the Efficacy and Safety of BuMA Supreme Drug Eluting Stent(DES)

Sponsor: Sino Medical Sciences Technology Inc.

View on ClinicalTrials.gov

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

Interventions

DEVICE

BuMA Supreme

Stent platform: cobalt-chromium alloy

Locations (1)

Zhongshan Hospital

Shanghai, China