At a glance
ClinicalIndex Comparison Record- ✓Age ≥20 years, male or non-pregnant female
- ✓Symptomatic ischemic heart disease: chronic stable angina with objective ischemia, or acute coronary syndromes (UA/NSTEMI) requiring elective or urgent PCI
- ✓Acceptable candidate for PCI with drug-eluting stents and for emergent CABG surgery
- ✓Willing to comply with follow-up evaluations
- ✕Pregnant, nursing, or planning pregnancy within 1 year post-procedure
- ✕History of bleeding diathesis, coagulopathy, or contraindications to antiplatelet/anticoagulant therapy; refusal of transfusion
- ✕Requiring chronic anticoagulation therapy for any reason
- ✕Hypersensitivity/contraindication to aspirin, heparin, ADP antagonists, cobalt chromium, stainless steel, platinum, sirolimus or analogs, or contrast that cannot be adequately pre-medicated
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating BuMA Supreme DES and Xience or Promus DES for Coronary Artery Disease. Completed, enrolled 1,629 participants across 58 sites in 8 countries.
Detailed 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.
Study Details
Timeline
Interventions
Implant BuMA Supreme stent only
Implant XIENCE family or Promus family only