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A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions.

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Trial Conditions
  • Coronary Artery Disease
  • Coronary Artery Stenosis
  • Coronary Disease
  • Coronary Stenosis
What is the purpose of this trial?

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 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.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

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, 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 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 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 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 %DS of ≥ 50% and < 100% with a 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 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 RCA lesion (within 3 mm of the ostium).

4. Lesion located within 3 mm of the origin of the LAD or 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.

Gender: Both
Steward Physician(s)
  • Stephen G Ellis, MD
  • Dean J Kereiakes, MD
  • Gregg W Stone, MD
  • Peter Staehr, MD
Trial Interventions
Device
  • Absorb BVS
  • XIENCE
Physician Researcher

Investigator Name:

  • Stephen G Ellis, MD
  • Dean J Kereiakes, MD
  • Gregg W Stone, MD
  • Peter Staehr, MD

Other Information

Sponsor: Abbott Vascular
Phase: N/A
Trial ID: NCT01751906
Volunteers:  Not Accepting Healthy Volunteers

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