ABSORB III- A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de novo Native Coronary Artery Lesions
Trial ID or NCT#
The ABSORB III RCT is a prospective randomized, single-blind, multi-center trial. It is the pivotal trial to support the US pre-market approval (PMA) of Absorb™ Bioresorbable Vascular Scaffold (BVS).
The ABSORB III includes additional two trials i.e. ABSORB III PK (pharmacokinetics) sub-study and ABSORB IV RCT trial which are maintained under one protocol because both trial designs are related, ABSORB IV is the continuation of ABSORB III and the data from ABSORB III and ABSORB IV will be pooled to support the ABSORB IV primary endpoint. Both the trials will evaluate the safety and effectiveness of Absorb BVS.
A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions.
- 1. 18 years of age.
- 2. Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.
- 3. Subject must have evidence of myocardial ischemia. In the absence of noninvasive ischemia, fractional flow reserve (FFR) must be done and indicative of ischemia.
- 4. Acceptable candidate for coronary artery bypass graft (CABG) surgery.
- 5. Female subject of childbearing potential who does not plan pregnancy for up to 1 year following the index procedure. For a female subject of childbearing potential a pregnancy test must be performed with negative results known within 7 days prior to the index procedure per site standard.
- 6. Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 1 year following the index procedure.
- 7. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 1 year following the index procedure.
- 1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or an adenosine diphosphate (ADP) antagonist is planned within 12 months after the procedure.
- 2. Hypersensitivity or contraindication to device material and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated. Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
- 3. Allergic reaction, hypersensitivity or contraindication to aspirin; or to clopidogrel and prasugrel and ticagrelor; or to heparin and bivalirudin, and therefore cannot be adequately treated with study medications.
- 4. Acute myocardial infarction (AMI: STEMI or NSTEMI) within 72 hours of the index procedure and both creatine kinase (CK) and CK-MB have not returned to within normal limits at the time of index procedure; or subject with stable angina or silent ischemia has CK-MB that is greater than normal limits at the time of the index procedure.
- 5. Subject is currently experiencing clinical symptoms consistent with new onset AMI (STEMI or NSTEMI), such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
- 6. Cardiac arrhythmia as identified at the time of screening for which at least one of the following criteria is met:
- (NOTE: Investigator should use discretion when enrolling subjects with high CHADS scores)
- 1. Subject requires coumadin or any other agent for chronic oral anticoagulation
- 2. Subject is likely to become hemodynamically unstable due to their arrhythmia
- 3. Subject has poor survival prognosis due to their arrhythmia
- 7. Left ventricular ejection fraction (LVEF) < 30%.
- 8. Subject has undergone prior percutaneous coronary intervention (PCI) within the target vessel during the last 12 months. Prior PCI within the non-target vessel or any peripheral intervention is acceptable if performed anytime >30 days before the index procedure, or between 24 hours and 30 days before the index procedure if successful and uncomplicated.
- 9. Future staged PCI either in target or non-target vessels or subject requires future peripheral interventions < 30 days after the index procedure.
- 10. Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
- 11. At the time of screening, the subject has a malignancy that is not in remission.
- 12. Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.
- 13. Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.
- 14. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin, dabigatran, apixaban, rivaroxaban or any other agent for any reason).
- 15. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
- 16. Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
- 17. Renal insufficiency. NOTE: Estimated glomerular filtration rate (GFR) can be based on Modification of Diet in Renal Disease (MDRD) equation or Cockcroft-Gault equation (CCG).
- 18. High risk of bleeding for any reason; has a history of bleeding diathesis or coagulopathy; has had a significant gastro-intestinal or significant urinary bleed within the past six months.
- 19. Cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc.).
- 20. Extensive peripheral vascular disease that precludes safe 6 French sheath insertion. Note: femoral arterial disease does not exclude the patient if radial access may be used.
- 21. Subject has life expectancy < 5 years for any non-cardiac cause or cardiac cause.
- 22. Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. This includes completion of Patient Reported Outcome instruments.
- 23. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
- 24. Vulnerable population.
- Angiographic Inclusion Criteria:
- Angiographic Exclusion Criteria:
- All exclusion criteria apply to the target lesion(s) or target vessel(s).
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