ABSORB II Randomized Controlled Trial (NCT01425281) | Clinical Trial Compass
CompletedNot Applicable
ABSORB II Randomized Controlled Trial
Belgium501 participantsStarted 2011-11
Plain-language summary
Prospective, randomized (2:1), active control, single blinded, parallel two-arm, multi-center clinical investigation using Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System (ABSORB BVS); compared to Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System (XIENCE)
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion Criteria:
General Inclusion Criteria
* Subject must be at least 18 years of age and less than 85 years of age.
* Subject must agree not to participate in any other clinical investigation for a period of three years following the index procedure. This includes clinical trials of medication and invasive procedures. Questionnaire-based studies, or other studies that are non-invasive and do not require medication are allowed.
* Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the ABSORB BVS system and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee.
* Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia).
* Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
* Subject must agree to undergo all clinical investigation plan-required follow-up visits, exercise testing, blood draw as well as adherence to European Society of Cardiology Guidelines and completion of quality of life questionnaires and of a subject diary to collect information including but not limited to tobacco usage, food intake, daily exercise and body weight
Angiographic Inclusion Criteria
* One or two de novo native lesions each located in a different epicardial vessel.
* If two treatable lesions meet the eligibility criteri…
What they're measuring
1
Absolute Difference (3 Years Post Nitrate- 3 Years Pre Nitrate) In-Scaffold Mean Lumen Diameter (MLD)
Timeframe: 3 years
2
Absolute Difference (3 Years Post-nitrate - Post Procedure Post-nitrate) In-Scaffold Minimum Lumen Diameter