BIOTRONIK- *A Prospective, Randomized, Multicenter Study to Assess the SaFety and Effectiveness of the Orsiro SiroLimus Eluting Stent in the Treatment Of Subjects With up to two de novo Coronary Artery Lesions* - IV
- Conditions
- coronary stenosisnarrowing of the arteries which supply the heart with blood1001108210003216
- Registration Number
- NL-OMON44708
- Lead Sponsor
- Biotronik
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 83
Clinical Inclusion Criteria
1. Subject must provide written informed consent
2. Subject is * 18 years and * 80 years old
3. For subject less than 20 years of age enrolled at a Japanese site, the patient and the patient*s legal representative must provide written informed consent before any study-specific tests or procedures are performed
4. Subject, target vessel(s) and lesion(s) are eligible for percutaneous coronary intervention (PCI)
5. Subject is an acceptable candidate for coronary artery bypass grafting (CABG)
6. Subject has clinical evidence of ischemic heart disease and/or a positive functional study, stable or unstable angina pectoris or documented silent ischemia, attributable to the target lesions
7. Subject is eligible for dual anti-platelet therapy (DAPT) treatment with acetylsalicylic acid (ASA) plus either, Clopidogrel, Prasugrel, Ticlopidine, or Ticagrelor. For subjects enrolled at a Japanese site, DAPT with ASA plus either Clopidogrel or Ticlopidine;Angiographic Inclusion Criteria
1. The target reference vessel diameter (RVD) is * 2.50 mm and * 3.75 mm assessed either visually or by online Quantitative Coronary Angiography.
2. Target lesion length is * 26 mm (assessed either visual estimate or by online Quantitative Coronary Angiography) and can be covered by one study stent
3. Single de novo lesion with * 50% and < 100% stenosis in up to 2 coronary arteries
4. Target vessel(s) Thrombolysis in Myocardial Infarction (TIMI) flow * 2
Clinical Exclusion Criteria;1. Subject has evidence of myocardial infarction within 72 hours prior to the index procedure
2. Subject with a *2 fold CK level or in absence of CK *3 fold CKMB level above the upper range limit within 24 hours prior to the procedure
3. Documented recent left ventricular ejection fraction (LVEF) * 30%
4. Subject is receiving oral or intravenous immunosuppressive therapy (i.e., inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
5. Subject has impaired renal function (i.e., serum creatinine > 2.5 mg/dl or 221 mmol/l, determined within 72 hours prior to intervention)
6. Target vessel(s) or side branch has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to the index procedure
7. The target lesion requires treatment with a device other than the pre-dilatation balloon prior to stent placement (including but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, cutting balloon etc.)
8. Planned intervention of non-target vessel(s) within 30 days after the index procedure
9. Planned intervention of target vessel(s) after the index procedure
10. Subject has a known allergy to contrast medium (that cannot be adequately premedicated), acetylsalicylic acid (ASA), heparin, PLLA, sirolimus, everolimus, cobalt chromium, nickel, or silicon carbide.
11. Subject is currently participating in another (medical device or drug) clinical study that has not reached the primary endpoint
12. Subject is pregnant and/or breast-feeding female or female who intends to become pregnant during the time of the study
13. Subject has serious medical illness (e.g., cancer, congestive heart failure) that may reduce life expectancy to less than 12 months
14. Planned surgery or dental surgical procedure within 6 months after index procedure
15. Three-vessel coronary artery disease at time of procedure
16. In the investigators opinion subject will not be able to comply with the follow up requirements;Angiographic Exclusion Criteria;1. Target lesion is located in the left main stem
2. Target lesion is located in or supplied by an arterial or venous bypass graft
3. Target lesion involves a side branch > 2.0 mm in diameter by visual estimate or by online quantitative coronary angiography
4. Ostial target lesion (within 5.0mm of vessel origin)
5. Thrombus, or possible thrombus, present in the target vessel
6. Heavily calcified lesion
7. Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off;Note: Multiple focal stenosis will be considered as a single lesion if they can be completely covered with 1 stent
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint for the main randomized controlled trial (RCT) is the<br /><br>12-month target vessel failure (TVF) rate, defined as any clinically-driven<br /><br>revascularization of the target vessel (TVR), target vessel Q-wave or non-Q<br /><br>wave myocardial infarction (MI), emergent CABG, or cardiac death -. The primary<br /><br>endpoint will be evaluated for all subjects who are randomized to one of the<br /><br>study stents (Orsiro or Xience Prime/Xpedition). The RCT will be considered<br /><br>complete with regard to the primary endpoint after all subjects have completed<br /><br>the 12-month follow-up. </p><br>
- Secondary Outcome Measures
Name Time Method