Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia

Randomized Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA (Percutaneous Transluminal Angioplasty) for the Treatment of Below the Knee Critical Limb Ischemia

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.

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