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PIONEER III Trial to Assess Safety and Efficacy of the BuMA Supreme™ Drug Coated Coronary Stent in Patients With Coronary Disease

NCT03168776 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1629

Last updated 2026-01-27

Study results available
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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

Interventions

DEVICE

BuMA Supreme DES

Implant BuMA Supreme stent only

DEVICE

Xience or Promus DES

Implant XIENCE family or Promus family only

Sponsors & Collaborators

  • Nova Vascular LLC

    collaborator UNKNOWN

  • Sino Medical Sciences Technology Inc.

    lead INDUSTRY

Principal Investigators

  • Martin B Leon, MD · Center for Interventional Vascular Therapy - Columbia University Medical Center / New York-Presbyterian Hospital, United States

  • Dean Kereiakes, MD · The Christ Hospital Physicians - Ohio Heart & Vascular, United States

  • Stephan Windecker, MD · Bern University Hospital Department for Cardiology, Switzerland

  • Shigeru Saito, MD · Shonan Kamakura General Hospital, Japan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-13
Primary Completion
2020-10-01
Completion
2024-10-01
FDA Device
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Japan
  • Netherlands
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03168776 on ClinicalTrials.gov