Coronary heart disease
Conditions
Interventions
Product Name: BioMatrix III DES System
Product Code: BioMatrix III stent
Pharmaceutical Form:
INN or Proposed INN: BIOLIMUS
Concentration unit: µg microgram(s)
Concentration type: range
Concentration
Sponsors
BIOSENSORS EUROPE SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years 2. Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation myocardial infarction and ST-elevation myocardial infarction 3. Presence of one or more coronary artery stenoses >50% in a native coronary artery or a saphenous bypass graft in a vessel with a reference diameter ranging from 2.25 to 4.0 mm which can be covered with one or multiple stents 4. No limitation to the number of treated lesions, number of vessels or lesion length but according to the randomization group. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnancy and breast feeding women 2. Known intolerance to aspirin, clopidogrel, heparin, stainless steel, sirolimus, biolimus, contrast material 3. Inability to provide informed consent 4. Currently participating in another trial before the first endpoint 5. Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period. Due to the broad inclusion criteria (“real world, all-comer” patients) enrollment of 80-90% of all patients undergoing percutaneous coronary intervention at each site is expected. A screening log will be kept at each site to assess how many eligible patients were actually included in the trial, and the monitor will be allowed to check the catheter lab diary.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the present study is to compare the safety and efficacy of the BioMatrixTM III Stent (Biolimus-eluting) with the CypherTM (Sirolimus-eluting) stent in a prospective, multicenter, randomized, controlled, non-inferiority trial in patients undergoing percutaneous coronary intervention in routine clinical practice.;Secondary Objective: At 30 d, 6 mo, 9 mo, 1, 2, 3, 4 & 5 yr: Justified/non-justified target lesion revascularization (TLR) and target vessel revascularization (TVR) Composite of cardiac death, myocardial infarction, justified TVR Target Vessel Failure Cardiac/Non cardiac death MI Angiographic and clinical stent thrombosis By QCA analysis at 9 mo: in-stent and in-segment binary restenosis rate in-stent and in-segment minimal luminal diameter in-segment percent diameter stenosis in-stent and in-segment late luminal loss Device success: <20% residual stenosis (by QCA), using the study device Lesion success: <20% residual stenosis (by QCA), using any PCI method Procedural success: < 20% residual stenosis (by QCA) using any PCI method, without death, MI, or TVR;Primary end point(s): The primary outcome is major adverse cardiac events (MACE) defined as a composite of cardiac death, myocardial infarction (Q-wave and non-Q wave), or justified target vessel revascularization (TVR) within 9 months. Endpoint of the Angiographic Study The principal endpoint of the angiographic study in the pre-specified group of patients undergoing repeat angiography at nine months after stent implantation is in-stent percent diameter stenosis (% DS). | — |
Countries
Netherlands
Outcome results
None listed