Trials / Active Not Recruiting
Active Not RecruitingNCT02698839
A Study to Evaluate the Efficacy and Safety of BuMA Supreme Drug Eluting Stent(DES)
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
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 539 (estimated)
- Sponsor
- Sino Medical Sciences Technology Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Realizing even more uniform and complete endothelial coverage, BuMA Supreme™ biodegradable drug coating coronary stent system comprises a new generation of biodegradable drug eluting stent under development by SINOMED. BuMA Supreme™ reconfigures BuMA™ DES utilizing a high caliber cobalt chromium platform coated with rapidly degrading PLGA scaffold.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BuMA Supreme | Stent platform: cobalt-chromium alloy |
| DEVICE | BuMA™ | Stent platform: stainless steel |
Timeline
- Start date
- 2015-12-01
- Primary completion
- 2018-03-01
- Completion
- 2025-12-01
- First posted
- 2016-03-04
- Last updated
- 2024-04-25
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02698839. Inclusion in this directory is not an endorsement.