Ischemia. Narrowing or obstructions of arteries below the knee
Conditions
Interventions
BTK revascularization with IN.PACT Amphirion* randomized to standard, uncoated
PTA balloons
Sponsors
Medtronic B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -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 -Reference vessel(s) diameter between 2 and 4 mm -Single or multiple lesions with >=70% DS of different lengths in one or more main afferent crural vessels including the tibioperoneal trunk -Angio-TL is one identifiable single solitary or series of multiple adjacent lesions with a DS >=70% and a cumulative length
Exclusion criteria
Exclusion criteria: -Planned major index limb amputation -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, SFA, popliteal arteries with length >=15 cm -Significant (>=50% DS) inflow lesion or occlusion in the ipsilateral Iliac, SFA and popliteal arteries left untreated -Previously implanted stent in the TL(s) -Aneurysm in the target vessel -Acute thrombus in the target limb -Failure to obtain a =50% DS and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. For the Angio-cohort: late lumen loss (LLL) of the target lesion as assessed by quantitative vascular angiography (QVA) either at 12 months or at a time of a Target Lesion Revascularization (TLR). 2. For all patients: cumulative *clinically driven* TLR of the target lesion in the (major) amputation free surviving patients at 12 months. *Clinically driven TLR* is defined as any TLR of the target lesion associated with: a. Deterioration of Rutherford Class and / or b. Increase in size of pre-existing wounds and / or c. Occurrence of a new wound(s) with options b. and c. as adjudicated by the wound healing core lab. 3. Composite of all cause death, major amputation and clinically driven TLR at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Amputation free survival at 30 days, 3 and 6 months, 1, 2, 3, 4 and 5 years 2. Rate of wound healing at 30 days, 6 months, 1 and 2 years 3. Amputation free survival and wound healing at 6 months, 1 and 2 years 4. Amputation free survival and resolved CLI at 6 months, 1 and 2 years 5. Death, amputation and clinically driven TLR at 30 days, 6 months, 1 and 2 years 6. Primary sustained clinical improvement: an improvement shift in the Rutherford classification of one class in amputation free, clinically driven TLR free surviving patients at 1 year 7. Secondary sustained clinical improvement: an improvement shift in the Rutherford classification of one class including the need for clinically driven TLR in amputation free surviving patients at 1 year 8. Quality of life assessment by EQ5D (EuroQol 5 Dimensions) at 6 months, 1, and 2 years vs. baseline 9. Walking capacity assessment by WIQ at 6 months, 1, and 2 years 10. MAE (Major Adverse Events) at 30 days, 6 months, 1, 2, 3, 4, 5 years (for definition refer to section 14 Terms & Definitons) 11. Device Success defined as exact deployment of the device according to the instructions for use as documented with suitable imaging modalities and in case of digital subtraction angiography, in at least 2 different imaging projections 12. Technical Success defined as successful vascular access and completion of the endovascular procedure and immediate morphological success with | — |
Countries
Netherlands
Outcome results
None listed