ABSORB III - A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de novo Native Coronary Artery Lesions Absorb™ is an investigational bioabsorbable vascular scaffold manufactured by Abbott. Absorb™ is referred to as a scaffold to indicate that it is a temporary structure.

  • STATUS
    Recruiting
Updated on 25 March 2021

Summary

ABSORB III - A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de novo Native Coronary Artery Lesions Absorb™ is an investigational bioabsorbable vascular scaffold manufactured by Abbott. Absorb™ is referred to as a scaffold to indicate that it is a temporary structure.

Description

Abbott's Absorb™ BVS is made of polylactide, a naturally dissolvable material that is commonly used in medical implants such as dissolving sutures. ABSORB III™ is the first U.S. clinical trial to evaluate the potential benefits and safety of Absorb™ in comparison to a medicated metallic cardiac stent, also called a drug eluting stent, in patients with CAD. Absorb BVS™ is approved for use outside of the US. More than 25,000 patients worldwide have received an Absorb BVS™. The clinical trial will enroll approximately 2,250 patients, the majority expected in the United States.

Details
Condition Coronary Artery Disease
Clinical Study IdentifierTX137628
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
AND OTHERS

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
AND OTHERS
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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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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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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