Prospective, multi-center, randomized 1:1, single blind trial using BuMA Supreme versus Resolute Integrity conducted in approximately 14 interventional cardiology centers in The Netherlands, Belgium, Spain and Portugal.
Clinical follow-up will occur at 1, 9 and 12 months post-stent implantation. All patients will undergo repeat angiography at 9 months follow-up. QCA assessment will be performed at baseline (pre- and post-procedure) and at 9 months follow-up.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. The subject is at least 18 years of age.
✓. Clinical evidence of ischemic heart disease and/or a positive territorial functional study.
✓. Documented stable angina pectoris (Canadian Cardiovascular Society (CCS) Classification 1, 2, 3 or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C, or IIIB-C), or documented silent ischemia
✓. The patient has a planned intervention of a single de-novo lesion in one or two separate major epicardial territories (LAD, LCX or RCA).
✓. Diameter Stenosis≥50 and\<100%.
✓. The visually estimated target lesion must be able to be covered by a single BuMA Supreme stent or a single Resolute Integrity stent (for available sizes refer to tables 1 and 2, page 20 and 21).
✓. The target lesion reference diameter must be visually estimated to be ≥2.5 mm and ≤4.5 mm in diameter.
✓. Written informed consent.
Exclusion criteria
✕. Female of child bearing potential (age \<50 years and last menstruation within the last 12 months). Subjects with age \<50 who underwent tubal ligation, ovariectomy or hysterectomy can be included.
✕. Evidence of ongoing acute myocardial infarction (AMI) in ECG and/or elevated cardiac biomarkers (according to local standard hospital practice) have not returned within normal limits at the time of procedure
. Patient suffered from stroke/TIA during the last 6 months.
✕. LVEF \<30%
✕. Platelet count \<100,000 cells/mm3 or \>400,000 cells/mm3, a WBC of \<3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
✕. Known renal insufficiency (e.g. serum creatinine \>2.5mg/dL, or creatinine clearance ≤30 mL/min), or subject on dialysis, or acute kidney failure (as per physician judgment).
✕. Patient undergoing planned surgery within 6 months with the necessity to stop DAPT.