SINGA‐PACLI.

Trial name or title	Singapore INfra‐Genicular Angioplasty with PAclitaxel‐eluting Balloon for Critical Limb Ischaemia (SINGA‐PACLI) Trial
Methods	Randomized controlled trial
Participants	Country: Singapore Setting: 2 hospitals Number of participants: 136 Inclusion criteria: Written informed consent Age > 21 years If female with childbearing potential, woman may not be pregnant at the study entry and must utilize reliable birth control for the duration of her participation into the study Willing and able to comply with the specified follow‐up evaluation Critical limb ischemia, Rutherford category 4 to 6 Stenosis (> 50% luminal loss) or occlusion of infragenicular arteries (defined as: distal to the infrapopliteal artery), including the tibiofibular trunk, anterior tibial artery, posterior tibial artery, and peroneal artery Infragenicular arterial lesions with length of < 20 cm At least 1 crural (anterior tibial, posterior tibial, or peroneal) artery with expected unobstructed runoff to ankle level after treatment Successful guidewire crossing of the trial lesion Exclusion criteria: Acute limb ischemia Subacute limb ischemia that requires thrombolysis as first treatment modality Previous major amputation of the affected limb (at or above the level of the ankle) Concurrent iliac or femoropopliteal artery disease not suitable for endovascular or surgical revascularization Concurrent iliac or femoropopliteal artery occlusion of > 10 cm, even if suitable for surgical or endovascular revascularization People without (expected) distal runoff to the index site Revascularization involving the same site within 30 days prior to the index procedure or planned revascularization of the same limb within 30 days of the index procedure Previous implanted stent at the index site Life expectancy < 6 months Factors making clinical follow‐up very difficult or impossible Known allergy to paclitaxel Known allergy to contrast media People taking warfarin or any other anticoagulants Known allergy to antiplatelet drugs or unable to tolerate dual antiplatelet therapy Active history of gastritis and other bleeding tendencies precluding use of dual antiplatelet therapy Known heparin‐induced thrombocytopenia (HIT type 2) Person unable or unwilling to tolerate contrast media Estimated glomerular filtration rate < 60 mL/minute/1.73 m2 unless person is receiving dialysis Left ventricular ejection fraction percentage < 35% (person may be at risk of life‐threatening irregular heartbeats) Either prothrombin time/partial thromboplastin time of > 1.5 times the median of normal that cannot be corrected for the time of the procedure or international normalized ratio > 1.6 that cannot be corrected for the time of the procedure Thrombocytopenia of platelet count < 50,000 /µL (50 x 109/L) that cannot be corrected for the time of the procedure
Interventions	Uncoated balloon angioplasty device: unspecified DEB device: unspecified Drug used: paclitaxel Vessels treated: infrapopliteal arteries
Outcomes	Primary: Primary patency of the treated (index) site at 6 months Secondary: Limb‐salvage rate Clinical categorization of the treated ischemic leg by means of the Rutherford classification Minor amputation Infrapopliteal surgical bypass of the trial leg Infrapopliteal endovascular reintervention of the trial leg Primary patency of treated femoropopliteal sites Periprocedural complications Death Incremental cost‐effectiveness ratio
Starting date	December 2013
Contact information	Dr Bien Soo Tan, tan.bien.soo@sgh.com.sg Dr Farah Gillan Irani, farah.gillan.irani@sgh.com.sg
Notes	Sponsor: Singapore General Hospital No industrial support has been specified

ABI: ankle‐brachial index; CLI: critical limb ischemia; DEB: drug‐eluting balloon; DES: drug‐eluting stent; DS: diameter stenosis; EQ‐5D: Euro‐Qol Group 5‐Dimension Self‐Report Questionnaire; PA: popliteal artery; PAD: peripheral arterial disease; PSVR: peak systolic velocity ratio; PTA: percutaneous transluminal angioplasty; QoL: quality of life; MAE: major adverse events; MI: myocardial infarction; SFA: superficial femoral artery; STEMI: ST‐elevation myocardial infarction; TLR: target lesion revascularization; TVR: target vessel revascularization; WIQ: Walking Impairment Questionnaire.