ISRCTN15496770Completed未知
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 enrollmentStarted: May 11, 2017Last updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 316
Study Overview
Brief Summary
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30955402 (added 15/04/2019)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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