The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia (NCT03551496) | Clinical Trial Compass
CompletedPhase 3
The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia
United States201 participantsStarted 2018-08-31
Plain-language summary
Single phased global, prospective, multicenter clinical trial designed to demonstrate a superior patency rate and acceptable safety in below the knee arteries with lesions treated with the DES BTK Vascular Stent System vs. percutaneous transluminal angioplasty (PTA).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject is 18 years or older and has signed and dated the trial informed consent form (ICF)
✓. Subject is willing and able to comply with the trial testing, procedures and follow-up schedule
✓. Subject has chronic, symptomatic lower limb ischemia, determined by Rutherford categories 4 or 5 in the target limb, with wound(s) confined to toes/forefoot
✓. Subject is a male or non-pregnant female. If female of child-bearing potential, and if sexually active must be using, or agree to use, a medically-acceptable method of birth control as confirmed by the investigator
✓. Stenotic, restenotic or occlusive target lesion(s) located in the tibioperoneal trunk, anterior tibial, posterior tibial and/or peroneal artery(ies).
✓. Target lesion(s) must be at least 4cm above the ankle joint
✓. A single target lesion per vessel, in up to 2 vessels, in a single limb
✓. Degree of stenosis ≥ 70% by visual angiographic assessment
Exclusion criteria
✕. Life expectancy ≤ 1year
✕. Stroke ≤ 90 days prior to the procedure date
✕. Prior or planned major amputation in the target limb
✕. Previous surgery in the target vessel(s) (including prior ipsilateral crural bypass)
What they're measuring
1
Number of Participants With Primary Patency
Timeframe: 12 months
2
Number of Participants Free From Major Adverse Events (MAE)