Singapore INfra-Genicular Angioplasty With PAclitaxel-eluting Balloon for Critical Limb Ischaemia (SINGA-PACLI) Trial (SINGA-PACLI)

Inclusion Criteria:

• Written informed consent
• Age > 21 years
• If female patient with child bearing potential, patient may not be pregnant at the study entry and must utilize reliable birth control for the duration of her participation into the study
• Patient is willing and able to comply with the specified follow-up evaluation
• Critical Limb Ischaemia, Rutherford category 4 (ischaemic rest pain), 5 (minor tissue loss) or 6 (major tissue loss)
• Stenosis (>50% luminal loss) or occlusion of infra-genicular arteries (defined as: distal to the infra-popliteal artery), including the tibiofibular trunk, the anterior tibial artery, the posterior tibial artery and the peroneal artery
• Infragenicular arterial lesions with length of <20cm
• At least one 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 ischaemia
• Subacute limb ischaemia which 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 revascularisation
• Concurrent iliac or femoropopliteal artery occlusion of >10cm, even if suitable for surgical or endovascular revascularization
• Patients 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 of less than 6 months
• Factors making clinical follow-up very difficult or impossible
• Known allergy to paclitaxel
• Known allergy to contrast media
• Patients on Warfarin or any other anti-coagulants
• Known allergy to anti-platelet drugs (Aspirin/ Clopidogrel) (or) unable to tolerate dual anti-platelet drugs therapy
• Active history of gastritis and other bleeding tendencies precluding use of dual anti-platelet therapy
• Known heparin induced thrombocytopenia (HIT type 2)
• Patient unable or unwilling to tolerate contrast media
• eGFR less than 50 ml/min/1.73m2 unless patient is on dialysis.
• If the patient has significant heart disease and Left Ventricular Ejection Fraction Percentage (LVEF%) is less than 35 %.
• Either PT/PTT of >1.5 times the median of normal that cannot be corrected for the time of the procedure (or ) INR >1.6 that cannot be corrected for the time of the procedure
• Thrombocytopenia of platelet count <50,000 /µL (50 X 109/L) which cannot be corrected for the time of the procedure