BIOFLOW-V: BIOTRONIK * A Prospective Randomized Multicenter Study to Assess the SaFety and Effectiveness of the Orsiro SiroLimus Eluting Coronary Stent System in the Treatment Of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions * V
- Conditions
- coronary stenosisnarrowing of the arteries which supply the heart with blood1001108210003216
- Registration Number
- NL-OMON43649
- Lead Sponsor
- Biotronik
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 17
1.Subject is *18 years or the minimum age required for legal adult consent in the country of enrollment.
2.Subject is an acceptable candidate for PCI.
3.Subject is an acceptable candidate for CABG.
4.Subject has clinical evidence of ischemic heart disease, stable or unstable angina pectoris or documented silent ischemia.
5.Subject is eligible for dual anti-platelet therapy treatment with aspirin plus either, clopidogrel, prasugrel, ticagrelor or ticlopidine.
6.Subject has provided written informed consent.
7.Subject is willing to comply with study follow-up requirements.
stents.
1.Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation myocardial infarction (STEMI) within 72 hours prior to the index procedure.
2.Subject is hemodynamically unstable.
3.Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study.
4.Subject has a known allergy to contrast medium that cannot be adequately pre-medicated, or any known allergy to thienopyridine, aspirin, both heparin and bivalirudin, L-605 cobalt-chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten and nickel), acrylic, fluoropolymers, silicon carbide, PLLA, sirolimus or everolimus.
5.Revascularization of any target vessel within 9 months prior to the index procedure or previous PCI of any non-target vessel within 30 days prior to the index procedure.
6.Planned treatment of a lesion not meeting angiographic inclusion and exclusion criteria during the index procedure or after the index procedure.
7.Planned surgery within 6 months of index procedure unless dual antiplatelet therapy can be maintained throughout the peri-surgical period.
8.History of a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure.
9.Subjects with active bleeding disorders, active coagulopathy, or any other reason, who are ineligible for DAPT.
10.Subject will refuse blood transfusions.
11.Subject has documented left ventricular ejection fraction (LVEF) < 30% as evaluated by angiography, echocardiogram, radionuclide ventriculography or any non-invasive imaging method within 90 days prior to the index procedure.
12.Subject is dialysis-dependent.
13.Subject has impaired renal function (i.e., blood creatinine > 2.5 mg/dL or 221 *mol/L determined within 7 days prior to the index procedure).
14.Subject has leukopenia (i.e. < 3,000 white blood cells/mm3), thrombocytopenia (i.e. < 100,000 platelets/mm3) or thrombocytosis (i.e. > 700,000 platelet/mm3).
15.Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are permitted), or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus; diabetes mellitus is permitted).
16.Subject is receiving chronic anticoagulation (e.g. coumadin, dabigatran, apixaban, rivaroxaban or any other agent).
17.Subject has life expectancy of < 1 year.
18.Subject is participating in another investigational (medical device or drug) clinical study. Subjects may be concurrently enrolled in a post-market study, as long as the post-market study device, drug or protocol does not interfere with the investigational treatment or protocol of this study.
19.In the investigator*s opinion, subject will not be able to comply with the follow-up requirements.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint for the main randomized controlled trial (RCT) is Target<br /><br>lesion failure (TLF) rate at 12 months post*index procedure. TLF is defined as<br /><br>all cardiac death, target vessel Q-wave or non*Q-wave myocardial infarction<br /><br>(MI), or clinically driven target lesion revascularization (TLR).</p><br>
- Secondary Outcome Measures
Name Time Method