Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT02129634
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02129634
Study Brief:
Protocol Section:
NCT02129634