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NCT03168776 · ClinicalTrials.gov registry record · NA
PIONEER III Trial to Assess Safety and Efficacy of the BuMA Supreme™ Drug Coated Coronary Stent in Patients With Coronary Disease
A NA study of Coronary Artery Disease, sponsored by Sino Medical Sciences Technology.
- Completed
- Registry status
- NA
- Development phase
- 1,629
- Enrollment target
- 20
- Study locations
NCT03168776: Completed NA study of Coronary Artery Disease, sponsored by Sino Medical Sciences Technology.
NCT03168776 is a NA study of Coronary Artery Disease that has completed, run by Sino Medical Sciences Technology. The registered enrollment target is 1,629 participants, above the 1,280-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (27% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03168776, a NA study of Coronary Artery Disease, has completed, sponsored by Sino Medical Sciences Technology.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,629 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this trial is to compare the safety and efficacy of the SINOMED BuMA Supreme biodegradable coronary stent in patients with up to 3 coronary lesions to either the XIENCE or Promus durable polymer coronary stents. This prospective, global, multi-center, randomized 2:1, single blind study will enroll up to 1632 subjects at up to 130 investigational sites in North America, Japan, and Europe. Subjects will have clinical follow-up in-hospital and at 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years.
Primary Outcome
TLF is defined as the composite of cardiac death, target vessel related myocardial infarction (TV-MI), and clinically-driven target lesion revascularization (TLR)
Conditions Studied
Interventions
- DEVICE BuMA Supreme DES
- DEVICE Xience or Promus DES
Study Locations (20)
Florida
- Bethesda Hospital East/Daniel Heart and Vascular Center - Boynton Beach
- Clearwater Cardiovascular Consultants - Clearwater
- MediQuest Research Group Inc. - Ocala
- Cardiovascular Institute of Northwest Florida - Panama City
- Florida Hospital Tampa - Tampa
Michigan
- Northern Michigan Hospital d.b.a. McLaren Northern Michigan - Petoskey
- William Beaumont Hospital - Royal Oak
- Michigan Heart - Ypsilanti
Indiana
- Krannert Institute of Cardiology - Indianapolis
- St. Vincent's Medical Group - Indianapolis
Alabama
- Cardiology, PC - Birmingham
Arizona
- Dignity Health - Mercy Gilbert Medical Center / Chandler Regional Medical Center - Gilbert
California
- Smidt Heart Institute Cedars-Sinai Maedical Center - Los Angeles
Connecticut
- Yale University - New Haven
District of Columbia
- Medstar Washington HWospital Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,629 participants |
| Start Date | 2017-10-13 |
| Est. Completion | 2024-10-01 |
| Phase | NA |
What the finished NCT03168776 record still lists
NCT03168776 is an interventional study that assigns participants to a tested intervention. Its 1,629 participants enrollment target places it among the larger protocols in the corpus, above the 1,280-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (27% higher).
The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which BuMA Supreme DES is the first listed.
NCT03168776 names 20 study sites across 13 states, led by Florida, Michigan, Indiana.
Frequently Asked Questions
What is clinical trial NCT03168776 about?
NCT03168776 is a clinical study titled "PIONEER III Trial to Assess Safety and Efficacy of the BuMA Supreme™ Drug Coated Coronary Stent in Patients With Coronary Disease". The primary objective of this trial is to compare the safety and efficacy of the SINOMED BuMA Supreme biodegradable coronary stent in patients with up to 3 coronary lesions to either the XIENCE or Promus durable polymer coronary stents. This prospective, global, multi-center, randomized 2:1, single...
What is the current status of trial NCT03168776?
This trial is currently completed. It is a NA study. The enrollment target is 1,629 participants. The study started on 2017-10-13. Estimated completion is 2024-10-01.
What conditions does trial NCT03168776 study?
This clinical trial studies the following conditions: Coronary Artery Disease.
What interventions are being tested in trial NCT03168776?
The interventions under investigation include: BuMA Supreme DES (DEVICE), Xience or Promus DES (DEVICE).
Who is sponsoring clinical trial NCT03168776?
This trial is sponsored by Sino Medical Sciences Technology, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03168776 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03168776's enrollment target sits among peer trials
1,629 33rd of 219 higher than 187 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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