Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT02698839
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 RCT trial is a prospective, multicenter, randomized, non-inferiority registry trial. 539 subjects from about 40 interventional cardiology centers in China will be enrolled to evaluate In-stent late lumen loss(LLL) as the primary endpoint at 9 months. 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, RCT Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

539

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

DEVICE

BuMA™

Stent platform: stainless steel

Locations (1)

Zhongshan Hospital

Shanghai, China