Trial Search Results

ABSORB III Randomized Controlled Trial (RCT)

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Abbott Medical Devices

Stanford Investigator(s):

Intervention(s):

  • Device: Absorb BVS
  • Device: XIENCE

Phase:

N/A

Eligibility


General Inclusion Criteria:

   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.

General Exclusion Criteria:

   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:

   1. One or two de novo target lesions:

      1. If there is one target lesion, a second non-target lesion may be treated but the
      non-target lesion must be present in a different epicardial vessel, and must be
      treated first with a successful, uncomplicated result prior to randomization of
      the target lesion.

      2. If two target lesions are present, they must be present in different epicardial
      vessels and both must satisfy the angiographic eligibility criteria.

      3. The definition of epicardial vessels means the LAD, LCX and RCA and their
      branches. Thus, the patient must not have lesions requiring treatment in e.g.
      both the LAD and a diagonal branch.

   2. Target lesion(s) must be located in a native coronary artery with a visually estimated
   or quantitatively assessed % diameter stenosis (DS) of ≥ 50% and < 100% with a
   thrombolysis in myocardial infarction (TIMI) flow of ≥1 and one of the following:
   stenosis ≥ 70%, an abnormal functional test (e.g. fractional flow reserve, stress
   test), unstable angina or post-infarct angina.

      1. Lesion(s) must be located in a native coronary artery with RVD by visual
      estimation of ≥ 2.5 mm and ≤ 3.75 mm.

      2. Lesion(s) must be located in a native coronary artery with length by visual
      estimation of ≤ 24 mm.

      3. For Lead-In subjects with 3.0x18 mm Absorb BVS: lesion(s) must be located in a
      native coronary artery with RVD by visual estimation of ≥ 2.75 mm and ≤ 3.25 mm.
      The lesion length by visual estimation is ≥ 8 mm and ≤ 14 mm.

Angiographic Exclusion Criteria:

All exclusion criteria apply to the target lesion(s) or target vessel(s).

   1. Lesion which prevents successful balloon pre-dilatation, defined as full balloon
   expansion with the following outcomes:

      1. Residual %DS is a maximum of < 40% (per visual estimation), ≤ 20% is strongly
      recommended.

      2. TIMI Grade-3 flow (per visual estimation).

      3. No angiographic complications (e.g. distal embolization, side branch closure).

      4. No dissections National Heart Lung and Blood Institute (NHLBI) grade D-F.

      5. No chest pain lasting > 5 minutes.

      6. No ST depression or elevation lasting > 5 minutes

   2. Lesion is located in left main.

   3. Aorto-ostial right coronary artery (RCA) lesion (within 3 mm of the ostium).

   4. Lesion located within 3 mm of the origin of the Left Anterior Descending Artery (LAD)
   or left circumflex artery (LCX).

   5. Lesion involving a bifurcation with a:

      1. side branch ≥ 2 mm in diameter, or

      2. side branch with either an ostial or non-ostial lesion with diameter stenosis >
      50%, or

      3. side branch requiring dilatation.

   6. Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS or
   XIENCE stent:

      1. Extreme angulation (≥ 90°) proximal to or within the target lesion.

      2. Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.

      3. Moderate or heavy calcification proximal to or within the target lesion. If IVUS
      used, subject must be excluded if calcium arc in the vessel prior to the lesion
      or within the lesion is ≥ 180°.

   7. Vessel contains thrombus as indicated in the angiographic images or by IVUS or OCT.

   8. Lesion or vessel involves a myocardial bridge.

   9. Vessel has been previously treated with a stent at any time prior to the index
   procedure such that the Absorb BVS or XIENCE would need to cross the stent to reach
   the target lesion.

10. Vessel has been previously treated and the target lesion is within 5 mm proximal or
   distal to a previously treated lesion.

11. Target lesion located within an arterial or saphenous vein graft or distal to any
   arterial or saphenous vein graft.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting