NCT03168776

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

A Prospective Global Randomized Trial Assessing the Safety and Efficacy of the BuMA Supreme™ Biodegradable Drug Coated Coronary Stent System for Coronary Revascularization in Patients With Stable Coronary Artery Disease or Non-ST Segment Elevation Acute Coronary Syndromes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,629 (actual)
• Sponsor: Sino Medical Sciences Technology Inc. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	BuMA Supreme DES	Implant BuMA Supreme stent only
DEVICE	Xience or Promus DES	Implant XIENCE family or Promus family only

Timeline

• Start date: 2017-10-13
• Primary completion: 2020-10-01
• Completion: 2024-10-01
• First posted: 2017-05-30
• Last updated: 2026-01-27
• Results posted: 2026-01-27

Locations

58 sites across 8 countries: United States, Belgium, Canada, Japan, Netherlands, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study