Table 1 IN.PACT DEEP inclusion and exclusion criteria

(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