Status:
COMPLETED
AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 (Absorb™ BVS) in Japanese Population
Lead Sponsor:
Abbott Medical Devices
Conditions:
Coronary Artery Disease
Myocardial Ischemia
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Absorb™ BVS is currently in development at Abbott Vascular. Not available for sale in the US or Japan.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Creatine Kinase (CK) and Creatine Kinase - Muscle and Brain (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 Glomerular filtration rate (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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2019
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT01844284
Start Date
April 1 2013
End Date
January 16 2019
Last Update
October 8 2020
Active Locations (39)
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1
Nagoya Daini Red Cross Hospital
Nagoya, Aichi-ken, Japan, 466-8650
2
Fujita Health University
Toyoake-shi, Aichi-ken, Japan, 470-1192
3
ShinTokyo
Matsudo-shi, Chiba, Japan, 270-2232
4
Kokura Memorial Hospital
Kitakyushu-shi, Fukuoka, Japan, 802-8555