AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 (Absorb™ BVS) in Japanese Population
This trial is active, not recruiting.
|Conditions||coronary artery disease, myocardial ischemia|
|Treatments||xience prime®/xience xpedition™, absorb™ bvs|
|Start date||April 2013|
|End date||January 2015|
|Trial size||400 participants|
|Trial identifier||NCT01844284, 12-301|
Prospective, Randomized (2:1), active control, single-blind, non-inferiority, multicenter, Japanese Clinical Trial to evaluate the safety and effectiveness of Absorb™ BVS (AVJ-301) in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions in Japanese population by comparing to approved metallic drug eluting stent.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
Subjects receiving Absorb™ BVS
Subjects receiving XIENCE PRIME®/XIENCE Xpedition™
Target Lesion Failure (TLF), non-inferiority against the active control, XIENCE PRIME®/XIENCE Xpedition™
time frame: 12 months
Late Loss (LL) at 13 Months (Non-inferiority)
time frame: 13 months
Change in average lumen diameter (ALD), between pre- and post-nitrate injection by angiography (superiority)
time frame: 3 years
Change in average lumen area (ALA), from post-procedure to 3 years by IVUS (superiority)
time frame: 3 years
Percentage of treated segments (in scaffold or in-stent) that show ACh induced vaso-dilatation by angiography.
time frame: 4 years
Male or female participants at least 20 years old.
- Subject must be at least 20 years of age.
- Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.
- Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia) suitable for elective percutaneous coronary intervention (PCI).
- Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
- Subject must be able to take dual antiplatelet therapy for up to 1 year following the index procedure and anticoagulants prior/during the index procedure. Therefore the subject has no known allergic reaction, hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine or heparin.
- Female subject of childbearing potential must not be pregnant* at the index procedure and does not plan pregnancy for up to 1 year following the index procedure. * Except for non-pregnancy is apparent, negative pregnancy result within 7 days prior to the index procedure is required.
- 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.
- Subject agrees to not participate in any other investigational or invasive clinical study for a period of 13 months following the index procedure
- Elective surgery is planned within 1 year after the procedure that will require general anesthesia or discontinuing either aspirin or Thienopyridine.
- Subject has known hypersensitivity or contraindication to device material and its degredants (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.
- Subject had an acute myocardial infarction (AMI) within 72 hours of the index procedure
- The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes
- CK and CK-MB have not returned to within normal limits at the time of index procedure.
- Subject has an unstable cardiac arrhythmia which is likely to become hemodynamically unstable due to arrhythmia.
- Subject has a known left ventricular ejection fraction (LVEF) < 30% (LVEF may be obtained at the time of the index procedure if the value is unknown and the investigator believes it is necessary).
- The target vessel was treated by PCI within 12 months.
- Prior PCI within the non-target vessel 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.
- Subject requires future staged PCI either in target or non target vessels.
- Subject has a malignancy that is not in remission.
- Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.,). Note: corticosteroids are not included as immunosuppressant therapy, diabetes mellitus is not regarded as autoimmune disease.
- Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
- Subject has previously received or scheduled to receive radiotherapy to coronary artery (brachytherapy), or chest/mediastinum.
- Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin or any other agent for any reason).
- Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
- Subject has a documented or suspected cirrhosis of Child-Pugh ≥ Class B.
- Subject has known renal insufficiency;
- Dialysis at the time of screening.
- An estimated GFR < 30 ml/min/1.73m2
- Subject is high risk of bleeding, or difficult to have appropriate treatment;
- Has a history of bleeding diathesis or coagulopathy
- Has had a significant gastro-intestinal or significant urinary bleed within the past six months
- Has prior intracranial bleed
- Has prior intracranial bleed (including severe permanent neurologic deficit that seem to be caused by previous intracranial bleeding)
- Has known intracranial pathology that may cause intracranial bleeding per an investigator assessment (e.g. untreated aneurysm > 5 mm, arteriovenous malformation)
- Subject will refuse blood transfusions
- Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months,
- Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
- Subject has life expectancy < 3 year.
- 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.
- Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
- Subject whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate (e.g. subordinate hospital staff or sponsor staff) or subject is unable to read or write.
|Official title||A Clinical Evaluation of AVJ-301 (Absorb™ BVS), the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions in Japanese Population|
|Principal investigator||Takeshi Kimura, MD|
|Description||Absorb™ BVS is currently in development at Abbott Vascular. Not available for sale in the US or Japan.|
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