AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 (Absorb™ BVS) in Japanese Population (ABSORB JAPAN)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01844284
First received: April 29, 2013
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Myocardial Ischemia
Device: XIENCE PRIME®/XIENCE Xpedition™
Device: Absorb™ BVS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • Target Lesion Failure (TLF), non-inferiority against the active control, XIENCE PRIME®/XIENCE Xpedition™ [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    TLF is defined as a composite endpoint of cardiac death, myocardial infarction attributable to target vessel (TV-MI), and ischemia-driven target lesion revascularization (ID-TLR).


Secondary Outcome Measures:
  • Late Loss (LL) at 13 Months (Non-inferiority) [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
    LL = Minimum Lumen Diameter (MLD) post-procedure - MLD at follow-up

  • Change in average lumen diameter (ALD), between pre- and post-nitrate injection by angiography (superiority) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Nitrate injection is: Nitrate induced vaso-dilatation

  • Change in average lumen area (ALA), from post-procedure to 3 years by IVUS (superiority) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Percentage of treated segments (in scaffold or in-stent) that show ACh induced vaso-dilatation by angiography. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    ACh = acetylcholine


Estimated Enrollment: 400
Study Start Date: April 2013
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Absorb™ BVS
Subjects receiving Absorb™ BVS
Device: Absorb™ BVS
Subjects receiving Absorb™ BVS
Active Comparator: XIENCE PRIME®/XIENCE Xpedition™
Subjects receiving XIENCE PRIME®/XIENCE Xpedition™
Device: XIENCE PRIME®/XIENCE Xpedition™
Subjects receiving XIENCE PRIME®/XIENCE Xpedition™

Detailed Description:

Absorb™ BVS is currently in development at Abbott Vascular. Not available for sale in the US or Japan.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject must be at least 20 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 (e.g., stable or unstable angina, silent ischemia) suitable for elective PCI.
  4. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
  5. 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.
  6. 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.

  7. 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.
  8. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 13 months following the index procedure

Exclusion Criteria:

  1. Elective surgery is planned within 1 year after the procedure that will require general anesthesia or discontinuing either aspirin or Thienopyridine.
  2. 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.
  3. Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
  4. 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.
  5. Subject has an unstable cardiac arrhythmia which is likely to become hemodynamically unstable due to arrhythmia.
  6. 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).
  7. The target vessel was treated by PCI within 12 months.
  8. 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.
  9. Subject requires future staged PCI either in target or non target vessels.
  10. Subject has a malignancy that is not in remission.
  11. 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.
  12. Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
  13. Subject has previously received or scheduled to receive radiotherapy to coronary artery (brachytherapy), or chest/mediastinum.
  14. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin 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 cirrhosis of Child-Pugh ≥ Class B.
  17. Subject has known renal insufficiency;

    • Dialysis at the time of screening.
    • An estimated GFR < 30 ml/min/1.73m2
  18. 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
  19. Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months,
  20. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
  21. Subject has life expectancy < 3 year.
  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.
  23. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
  24. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01844284

Locations
Japan
Abbott Vascular Japan Co., Ltd.
Tokyo, Japan, 108-6304
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Takeshi Kimura, MD Kyoto University
  More Information

No publications provided

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01844284     History of Changes
Other Study ID Numbers: 12-301
Study First Received: April 29, 2013
Last Updated: April 23, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Abbott Vascular:
Absorb™ BVS
Angioplasty
Bioabsorbable
Bioreabsorbable
BVS
Coronary Artery Disease
Coronary Artery Endothelial Responsiveness
Coronary artery restenosis
Coronary artery stenosis
Coronary scaffold
Coronary Stent
Drug eluting stents
Everolimus
Myocardial ischemia
Stent thrombosis
Stents

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014