Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions

Launched by BIOTRONIK, INC. · Mar 10, 2015

Keywords

ClinConnect Summary

The BIOTRONIK BIOFLOW-V clinical trial is a prospective, multicenter, randomized, controlled trial combining data on the randomized subjects with data from two historical studies by employing a Bayesian approach.

Subjects with CAD that qualify for PCI with stenting will be screened per the protocol inclusion and exclusion criteria to achieve a total of up to 1,400 randomized subjects. Eligible subjects will be randomized in a 2:1 ratio, stratified by study center, to undergo percutaneous coronary revascularization with either the Orsiro Sirolimus Eluting Stent System (treatment group) or t...

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Eligibility criteria

• Inclusion Criteria:
• • 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.
• Each target lesion/vessel must meet all of the following angiographic criteria for the subject to be eligible for the trial:
• • 1. Subject has up to three target lesions in up to two separate target vessels (two target lesions in one vessel and one target lesion in a separate vessel).
• • 2. Target lesion must be de novo or restenotic lesion in native coronary artery; restenotic lesion must have been treated with a standard PTCA only.
• • 3. Target lesion must be in major coronary artery or branch (target vessel).
• • 4. Target lesion must have angiographic evidence of ≥ 50% and \< 100% stenosis (by operator visual estimate). If the target lesion is \< 70% stenosed, clinical evidence of ischemia by positive functional study, CT, electrocardiography, FFR, or post infarct angina.
• • 5. TIMI flow \> 1.
• • 6. Target lesion must be ≤ 36 mm in length by operator visual estimate.
• • 7. Target vessel RVD of 2.25-4.0 mm by operator visual estimate.
• • 8. Target lesion must be treatable with a maximum of two overlapping stents.
• Exclusion Criteria:
• • 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. Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment.
• • 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% 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 μmol/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.
• Subjects will be excluded from the trial if any of the target lesions/vessels meets any of the following angiographic criteria:
• • 1. Target lesion is located within a saphenous vein graft or arterial graft.
• • 2. Target lesion is a restenotic lesion that was previously treated with a bare metal or drug eluting stent (in-stent restenosis).
• 3. Target lesion has any of the following characteristics:
• • 1. Lesion location is within the left main coronary artery, or within 3 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX).
• • 2. Involves a side branch of \> 2.0 mm in diameter. Note: Lesions within 3 mm of the origin of the right coronary artery may be treated.
• • 4. Target vessel/lesion is excessively tortuous/angulated or is severely calcified, that would prevent complete inflation of an angioplasty balloon. This assessment should be based on visual estimation.
• • 5. Target vessel has angiographic evidence of thrombus.
• • 6. Target lesion is totally occluded (100% stenosis).
• • 7. Target vessel was treated with brachytherapy any time prior to the index procedure.