(A) General inclusion criteria | |
i.1 Age ≥ 18 years and ≤85 years | |
i.2 Patient or patient’s legal representative has been informed of the nature of the study, agrees to participate, and has signed an EC-approved consent form | |
i.3 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 | |
i.4 Patient has documented chronic critical limb ischemia (CLI) in the target limb prior to the study procedure with Rutherford category 4, 5, or 6 | |
i.5 Life expectancy >1 year in the investigator’s opinion | |
(B) General exclusion criteria | |
e.1 Patient unwilling or unlikely to comply with follow-up schedule | |
e.2 Planned major index limb amputation | |
(C) General angiographic inclusion criteria | |
i.6 Reference vessel diameter(s) between 2 and 4 mm | |
i.7 Single or multiple lesions with ≥70% DS of different lengths in one or more main afferent crural vessels including tibioperoneal trunk | |
i.8 At least one non-occluded crural vessel with angiographically documented run-off to the foot either directly or through collaterals | |
(D) General angiographic exclusion criteria | |
e.3 Lesion and/or occlusions located in or extending to the popliteal artery or below the ankle joint space | |
e.4 Inflow lesion or occlusion in the ipsilateral iliac, SFA, or popliteal arteries with length ≥15 cm | |
e.5 Significant (≥50% DS) inflow lesion or occlusion in the ipsilateral iliac, SFA, or popliteal arteries left untreated | |
e.6 Previously implanted stent in the TL(s) | |
e.7 Aneurysm in the target vessel | |
e.8 Acute thrombus in the TL | |
(E) General procedural exclusion criteria | |
e.9 Failure to obtain <30% residual stenosis in pre-existing, hemodynamically significant (≥50% DS and <15 cm length) inflow lesions in the ipsilateral iliac, SFA, or popliteal artery. DES and/or DEB was not allowed for the treatment of inflow lesions | |
e.10 Failure to cross the TL with a 0.014′ guide wire | |
e.11 Use of alternative therapy, e.g., atherectomy, cutting balloon, laser, radiation therapy, DES as part of the index procedure | |
(F) Angiographic cohort angiographic inclusion criteria | |
a.i.1 Angio-TL is one identifiable single solitary or a series of multiple adjacent lesions with a DS ≥ 70% and a cumulative length ≤ 100 mm that can be covered by a single IN.PACT Amphiron™ (10-mm balloon landing zone in both edges is mandatory) | |
a.i.2 Angio-TL is the only lesion in that vessel (only 1 Angio-TL per patient is allowed) | |
(G) Angiographic cohort general exclusion criteria | |
a.e.1 GFR <30 ml/min except for patients with renal end-stage disease on chronic hemodialysis |