ABSORB IV Randomized Controlled Trial

  • STATUS
    Recruiting
  • sponsor
    Abbott Cardiovascular
Updated on 23 November 2020
stenosis
coronary artery disease
unstable angina
infarct
ischemia
stable angina
bypass graft
exercise stress test

Summary

ABSORB IV Randomized Controlled Trial

Description

Clinical Evaluation of the Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de novo Native Coronary Artery Lesions

If the patient agrees to take part in this Study, they may or may not receive any direct medical benefit. The use of a drug-eluting stent, like XIENCE, has been shown to be able to reduce the re-narrowing of the heart artery. There may be a potential benefit from the Absorb BVS in decreasing the rate of re-narrowing as well.

The fact that the Absorb BVS will not be a permanent part of the wall of the artery may have a long term benefit:

  • It may be easier to do bypass surgery on the affected vessel if needed;
  • It may be easier to do certain diagnostic imaging procedures on the heart if needed;
  • The heart artery may be able to adapt better to changing needs in blood flow in the absence of a device.

The long-term effects and possible benefits of the Absorb BVS are not yet known.

Details
Condition Coronary Artery Disease
Clinical Study IdentifierTX139476
SponsorAbbott Cardiovascular
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 0 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Coronary Artery Disease??
Subject must be at least 18 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, 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
Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
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
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 1 year following the index procedure
Angiographic Inclusion Criteria
One or two _de novo_ target lesions
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
If two target lesions are present, they must be present in different epicardial vessels and both must satisfy the angiographic eligibility criteria
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
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
Lesion(s) must be located in a native coronary artery with RVD by visual estimation of ≥ 2.50 mm and ≤ 3.75 mm
Lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 24 mm
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

Exclusion Criteria

Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure
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
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
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
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
Subject has a cardiac arrhythmia as identified at the time of screening for which at least one of the following criteria is met
Subject requires coumadin or any other agent for chronic oral anticoagulation
Subject is likely to become hemodynamically unstable due to their arrhythmia
Subject has poor survival prognosis due to their arrhythmia
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
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
Subject requires future staged PCI either in target or non-target vessels or subject requires future peripheral interventions < 30 days after the index procedure
Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants
At the time of screening, the subject has a malignancy that is not in remission
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
Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum
Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin, dabigatran, apixaban, rivaroxaban 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 hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B
Subject has renal insufficiency as defined as an estimated GFR < 30 ml/min/1.73m2 or dialysis at the time of screening
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
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.)
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
Subject has life expectancy < 5 years for any non-cardiac cause or cardiac cause
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
Subject is currently participating in another clinical trial that has not yet completed its primary endpoint
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)
Lesion which prevents successful balloon pre-dilatation, defined as full balloon expansion with the following outcomes
Residual %DS is a maximum < 40% (per visual estimation), ≤ 20% is strongly recommended
TIMI Grade-3 flow (per visual estimation)
No angiographic complications (e.g. distal embolization, side branch closure)
No dissections NHLBI grade D-F
No ST depression or elevation lasting > 5 minutes
Lesion is located in left main
Aorto-ostial RCA lesion (within 3 mm of the ostium)
Lesion located within 3 mm of the origin of the LAD or LCX
Lesion involving a bifurcation with a
side branch ≥ 2 mm in diameter, or
side branch with either an ostial or non-ostial lesion with diameter stenosis > 50%, or
side branch requiring dilatation
Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS or XIENCE stent
Extreme angulation (≥ 90°) proximal to or within the target lesion
Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion
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°
Vessel contains thrombus as indicated in the angiographic images or by IVUS or OCT
Lesion or vessel involves a myocardial bridge
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
Vessel has been previously treated and the target lesion is within 5 mm proximal or distal to a previously treated lesion
Target lesion located within an arterial or saphenous vein graft or distal to any arterial or saphenous vein graft
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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