The PIONEER III Study, SIN-US-001

• Research type

  Research Study

• Full title

  A Prospective Multicenter Global Randomized Controlled 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

• IRAS ID

  234232

• Contact name

  Anthony Mathur

• Contact email

  a.mathur@qmul.ac.uk

• Sponsor organisation

  Sino Medical Sciences Technology, Inc. (SINOMED)

• Clinicaltrials.gov Identifier

  NCT03168776

• Duration of Study in the UK

  5 years, 5 months, 30 days

• Research summary

  This SINOMED study is a prospective Multicenter Global Randomized Controlled 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: BuMA Supreme™ Biodegradable Drug Coated Coronary Stent System (BuMA DES).

  Subjects will be randomized 2:1 to the following treatment groups (stratified by acute vs. non-acute coronary syndrome, diabetes status, and study site):

  • Intervention: Treatment with the BuMA DES
  • Control: Treatment with Xience or Promus everolimus-eluting stent systems

  Subjects will undergo follow-up at 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years. Follow-up at 30 days and 12 months will be clinic visits, while the 6-month follow-up and annual follow-up at 2-5 years will be via telephone contact (or optional clinic visit). Subjects in whom no study stent is implanted will be followed to 12 months only. The study will take place at up to 130 sites in North America, Japan, and Europe. A minimum of 50% of subjects will be enrolled at North American sites, and no single center will enroll more than 10% of all subjects.

• REC name

  London - Stanmore Research Ethics Committee

• REC reference

  18/LO/0378

• Date of REC Opinion

  9 May 2018

• REC opinion

  Further Information Favourable Opinion