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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 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.

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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.

Conditions Studied

Coronary Artery Disease

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

FieldValue
Enrollment Target 1,629 participants
Start Date 2017-10-13
Est. Completion 2024-10-01
Phase NA

Sponsor

Sino Medical Sciences Technology

1 total trials

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What the Registry Record Tells You About NCT03168776

The ClinicalTrials.gov registry entry for NCT03168776 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1,629 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,280-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (27% higher). The listed sponsor is Sino Medical Sciences Technology, which has 1 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.