study of in.pact amphirion™ drug eluting balloon vs. standard pta for the treatment of below the knee critical limb ischemia

Conditions: Critical Lower Limb Ischemia

Summary: this is a prospective, multi-center, randomized (2:1) trial of symptomatic patients with critical limb ischemia (cli) secondary to atherosclerotic lesions (stenotic or occluded) of the infrapopliteal vessels. patients will undergo a percutaneous transluminal endovascular procedure with either the in.pact amphirion™ drug eluting balloon or with a standard (percutaneous transluminal angioplasty) pta balloon. patients will be followed with pre-study, post-study, and follow-up evaluations.


Eligibility criteria:
inclusion criteria: general inclusion criteria * age ≥18 years and ≤85 years * patient or patient's legal representative have been informed of the nature of the study, agrees to participate and has signed an ethical committee approved consent form * female patients of childbearing potential have a negative pregnancy test ≤7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation * patient has documented chronic critical limb ischemia (cli) in the target limb prior to the study procedure with rutherford category 4, 5 or 6 * life expectancy \>1 year in the investigator's opinion general angiographic inclusion criteria * reference vessel(s) diameter between 2 and 4 mm * single or multiple lesions with ≥70% diameter stenosis (ds) of different lengths in one or more main afferent crural vessels including the tibioperoneal trunk * at least one non occluded crural vessel with angiographically documented run-off to the foot either direct or through collaterals angiographic inclusion criteria for late lumen loss (lll) assessment * angio-target lesion (tl) is one identifiable single solitary or series of multiple adjacent lesions with a diameter stenosis (ds) ≥70% and a cumulative length ≤100 mm that can be covered by a single in.pact amphirion™ (10 mm balloon landing zone in both edges is mandatory) * angio-target lesion (tl) is the only lesion in that vessel (only one angio-tl per patient is allowed) exclusion criteria: general exclusion criteria * patient unwilling or unlikely to comply with follow-up schedule * planned major index limb amputation general angiographic exclusion criteria * lesion and / or occlusions located or extending in the popliteal artery or below the ankle joint space * inflow lesion or occlusion in the ipsilateral iliac, superficial femoral artery (sfa), popliteal arteries with length ≥15 cm * significant (≥50% ds) inflow lesion or occlusion in the ipsilateral iliac, superficial femoral artery (sfa) and popliteal arteries left untreated * previously implanted stent in the target lesions(s) * aneurysm in the target vessel * acute thrombus in the target limb general procedural exclusion criteria * failure to obtain a \<30% residual stenosis in pre-existing, hemodynamically significant (≥50% diameter stenosis (ds) and \<15 cm length) inflow lesions in the ipsilateral iliac, sfa and popliteal artery. no drug eluting stents (des) and / or drug eluting balloon (deb) allowed for the treatment of inflow lesions. * failure to cross the tl with a 0.014" guide wire * use of alternative therapy, e.g. atherectomy, cutting balloon, laser, radiation therapy, des as part of the index procedure angiographic cohort general exclusion criteria: - glomerular filtration rate (gfr) \<30 ml/min except for patients with renal end stage disease on chronic haemodialysis

Keywords: btk cli pta