Chronic Limb Threatening Ischemia, Infrapopliteal Arterial Occlusive Disease
Conditions
Keywords
chronic limb threatening ischemia, infrapopliteal arteries angioplasty, limb salvage, endovascular revascularization
Brief summary
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
Interventions
PROCEDUREballoon angioplasty
endovascular angioplasty of infrapopliteal arteries performed using standard balloon catheters under fluroscopic guidance to restore blood flow to the ischemic area
Sponsors
Sohag University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
due to nature of the intervention procedures masking was not feasible the number of infrapopliteal arteries treated is clearly documented in procedural reports and imaging and therefore both participants and treating physicians were aware of the assigned intervention
Intervention model description
Participants will be assigned to one of two parallel groups based on the revascularization strategy received : single vessel infrapopliteal angioplasty or multiple vessel infrapoplital angioplasty . Each participant will remain in the same intervention group throughout the study period and outcomes will be comapred between the two groups
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. patients aged 40 years or older 2. patients with Rutherford category 4 and 5 3. patients with angiographic evidence of infrapopliteal vessel occlusive disease -
Exclusion criteria
1. patients who refuse to participate in the study 2. patients with isolated proximal arterial disease (e.g SFA or popliteal ) without infrapopliteal involvement 3. patients who develop acute thrombosis , flow limiting dissection or perforation in the infrapopliteal arteries during intervention -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| limb salvage rate | 6 months ( with optional follow up at 12 months ) | percentage of patients who remain free from major lower limb amputation during the period of follow up after angioplasty |
Countries
Egypt
Contacts
Primary ContactMahmoud Abdelrahman hafez, Master's student
Backup ContactMahmoud El-saedy, MB BCh ( candidate )
Outcome results
None listed