Prospective, single-arm and non-sponsored trial to evaluate potential of selected mechanical debulking techniques to eliminate thrombolysis and/or open surgery from initial therapy of acute and subacute ischaemia of lower limbs

Charles University0 sites316 target enrollmentMay 11, 2017

Overview

Registry

who.int

Start Date

May 11, 2017

End Date

December 31, 2016

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Charles University

•1\. Symptomatic lower limb(s) ischaemia: acute, categories IIA or IIB (the Rutherford classification of acute limb ischaemia), onset of symptoms: 14 days or less
•2\. Symptomatic subacute lower limb ischemia: categories 3\-6 (the Rutherford classification for chronic limb ischaemia), severe claudication, critical limb ischemia, ischemic tissue defect, rest ischemic pain, symptoms duration: from 15 days to 3 months
•3\. Aged 18 years and over
•4\. Written informed consent given prior to study entry (or court agreement in unconscious patient)
•5\. Occluded graft and/or native artery supplying lower limb (supratibial location, lumen diameter 4 mm or more at the site of occlusion, stented or non\-stented, with or without calcifications, with or without additional infrapopliteal occlusions/stenoses)
•6\. Diagnosis of vascular occlusion on digital subtraction angiogram after informed consent is obtained
•7\. Ability to traverse the occlusion intraluminally with guidewire

•1\. Serious hemodynamic circulatory incompetence contraindicating application of x\-ray contrast material
•2\. Anatomy excluding endovascular approach and treatment
•3\. Category III acute lower limb ischemia (irreversible)
•4\. Occluded vessel diameter less 4 mm, arterial spasm resistant to nitroglycerine
•5\. Written informed consent or court agreement were not obtained
•6\. Situation when primary surgical approach is necessary