Revascularization of Single Vesrus Multiple Infrapopliteal Vessels in Chronic Limb Threatening Ischemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorSohag University
About this trial
This interventional prospective study aims to assess the effectiveness of single vessel versus multiple vessel infrapopliteal angioplasty in patients with chronic threatening limb ischemia . The study compares limb salvage rates and clinical outcomes across two groups over a defined follow up period
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients aged 40 years or older 2. patients with Rutherford category "4" and "5" 3. patients with angiographic evidence of infrapopliteal vessel occlusive disease -
Disqualifiers
patients who refuse to participate in the study
patients with isolated proximal arterial disease (e.g SFA or popliteal ) without infrapopliteal involvement
patients who develop acute thrombosis , flow limiting dissection or perforation in the infrapopliteal arteries during intervention -
Trial design
Design model
Parallel
Treatments tested in this trial
balloon angioplasty
Procedure/Surgeryendovascular angioplasty of infrapopliteal arteries performed using standard balloon catheters under fluroscopic guidance to restore blood flow to the ischemic area
Treatment groups
40 Participants
are divided into 3 treatment groupsGroup A: three vessel revascularizationExperimental treatment 1 intervention
Group B: two vessel revascularizationExperimental treatment 1 intervention
Group C: single vessel revascularizationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
limb salvage rate
percentage of patients who remain free from major lower limb amputation during the period of follow up after angioplasty
Time frame
6 months ( with optional follow up at 12 months )2
limb salvage rate
percentage of patients who avoid major amputation during the period of follow up following angioplasty procedure
Time frame
6 months ( with optional follow up at 12 months )Sponsors and contacts
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Source ClinicalTrials.gov