©2022 Stanford Medicine
ABSORB III Randomized Controlled Trial (RCT)
Not Recruiting
Trial ID: NCT01751906
Purpose
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.
Official Title
A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions.
Stanford Investigator(s)
Eligibility
General Inclusion Criteria:
1. Subject must be at least 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 (e.g., stable, unstable angina,
post-infarct angina or silent ischemia) suitable for elective PCI. Subjects with
stable angina or silent ischemia and < 70% diameter stenosis must have objectives sign
of ischemia as determined by one of the following, echocardiogram, nuclear scan,
ambulatory ECG or stress ECG). In the absence of noninvasive ischemia, fractional flow
reserve (FFR) must be done and indicative of ischemia.
4. Subject must be an 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.
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 ≥ 2.50 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: lesions (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.
General Exclusion Criteria:
1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP
antagonist is planned within 12 months after the procedure.
2. Subject has known 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. Subject has known 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. Subject had an 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. Subject has a cardiac arrhythmia as identified at the time of screening for which at
least one of the following criteria is met:
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. Subject has a left ventricular ejection fraction (LVEF) < 30% assessed by any
quantitative method, including but not limited to echocardiography, MRI,
Multiple-Gated Acquisition (MUGA) scan, contrast left ventriculography, PET scan, etc.
LVEF may be obtained within 6 months prior to the procedure for subjects with stable
CAD. For subjects presenting with ACS, LVEF must be assessed during the index
hospitalization (which may include during the index procedure by contrast left
ventriculography) but prior to randomization in order to confirm the subject's
eligibility.
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. Subject requires 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. Subject has renal insufficiency as defined as an estimated GFR < 30 ml/min/1.73m2 or
dialysis at the time of screening.
18. Subject is 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. Subject has had a 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. Subject has 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. Subject is part of a vulnerable population who, in the judgment of the investigator,
is unable to give Informed Consent for reasons of incapacity, immaturity, adverse
personal circumstances or lack of autonomy. This may include: Individuals with mental
disability, persons in nursing homes, children, impoverished persons, persons in
emergency situations, homeless persons, nomads, refugees, and those incapable of
giving informed consent. Vulnerable populations also may include members of a group
with a hierarchical structure such as university students, subordinate hospital and
laboratory personnel, employees of the Sponsor, members of the armed forces, and
persons kept in detention.
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 < 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.
Intervention(s):
device: Absorb BVS
device: XIENCE
device: Absorb BVS
device: XIENCE
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305