The ABSORB BTK (Below The Knee) Clinical Investigation (NCT01341340) | Clinical Trial Compass
TerminatedNot Applicable
The ABSORB BTK (Below The Knee) Clinical Investigation
Stopped: Discontinued due to poor enrollment. Insufficient number of patients enrolled to permit a statistically rigorous assessment of safety and efficacy.
Belgium2 participantsStarted 2011-11
Plain-language summary
The purpose of the ABSORB BTK Clinical Investigation is to evaluate the safety and efficacy of the Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS) in subjects with critical limb ischemia (CLI) following percutaneous transluminal angioplasty (PTA) of the tibial arteries.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Subject must be at least 18 and ≤ 80 years of age.
✓. History of symptomatic critical limb ischemia (CLI) (Rutherford Becker Clinical Category 4 or 5).
✓. Subject is able to take at least one type of thienopyridine (e.g. clopidogrel) and acetylsalicylic acid (eg. Aspirin/ASA).
✓. The subject must have a life-expectancy of more than 1 year.
✓. Female subjects of childbearing potential must have had a negative pregnancy test within 14 days before treatment, must not be nursing at the time of treatment, and must also agree at time of consent to use birth control during participation in this study up to and including the angiographic follow-up at 1 year.
✓. Subject has been informed of the nature of the study, agrees to its provisions, and has signed the informed consent form prior to any study related procedure.
✓. Subject must agree to undergo all protocol-required follow-up examinations and requirements at the investigational site.
✓. Subject must agree not to participate in any other clinical investigation for a period of one year following the index procedure. This includes clinical trials of medications and invasive procedures. Questionnaire-based studies, or other studies that are non-invasive and do not require medication are allowed.
Exclusion criteria
✕. Subject is unable to understand or unwilling to cooperate with study procedures.
✕. The subject is mentally ill or belongs to a vulnerable population.
What they're measuring
1
Freedom from major adverse limb events (MALE) within 1 year or peri-procedural (30-day) death (POD) (MALE+POD).