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Table 2 IN.PACT DEEP trial secondary endpoints

From: IN.PACT Amphirion paclitaxel eluting balloon versus standard percutaneous transluminal angioplasty for infrapopliteal revascularization of critical limb ischemia: rationale and protocol for an ongoing randomized controlled trial

(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 1 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 1 class including the need for clinically driven TLR in amputation-free surviving patients at 1 year
(8) QoL assessment by EQ5D at 6 months, 1 and 2 years vs. baseline
(9) Walking capacity assessment by WIQ at 6 months, 1 and 2 years
  MAE at 30 days, 6 months, 1, 2, 3, 4, and 5 years
(10) Device success defined as the exact deployment of the device according to the instructions for use as documented with suitable imaging modalities and, in the case of digital subtraction angiography, in at least two different imaging projections
(11) Technical success defined as successful vascular access and completion of the endovascular procedure and immediate morphological success with ≤50% residual diameter reduction of the treated lesion on completion angiography
(12) Procedural success defined as combination of technical success, device success and absence of procedural complications
(13) For the Angio cohort: improvement in 12 months of percent diameter stenosis (%DS) of the TL assessed by quantitative vascular angiography
(14) Days of hospitalization