E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Acute coronary syndrome versus no acute coronary syndrome.
De novo versus non de-novo lesions.
Diabetic versus non diabetic patients. |
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E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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).
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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According to the sharter of data safety monitoring board (stopping rules) and otherwise according to the protocol (Clinical follow-up up to 2012) |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 6 |