Actively Recruiting
Revascularization of Single Versus Multiple Infrapopliteal Vessels in Chronic Limb Threatening Ischemia: Limb Salvage Rate
Led by Sohag University · Updated on 2025-07-16
40
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of single vessel versus multiple vessel infrapopliteal angioplasty in patients with chronic threatening limb ischemia. This study aims to compare limb salvage rates and clinical outcomes among different treatment approaches over a follow-up period. The study is interventional and assesses how these procedures impact blood flow restoration and limb preservation in affected patients. Participants will receive balloon angioplasty, a procedure performed using standard balloon catheters under fluoroscopic guidance to open blocked infrapopliteal arteries. There are three study groups: one receiving angioplasty of all three infrapopliteal arteries, another receiving angioplasty of two arteries, and a third group treated on only one artery. This allows comparison of outcomes based on the number of vessels treated. During the study, participants will be monitored for limb salvage at 6 months, with an optional follow-up at 12 months to assess long-term results. Researchers will observe clinical outcomes related to blood flow restoration and limb health. The study involves no masking or randomization, and participants will be followed closely to evaluate the effectiveness of each angioplasty approach in preserving the affected limb.
CONDITIONS
Brief Title
Revascularization of Single Vesrus Multiple Infrapopliteal Vessels in Chronic Limb Threatening Ischemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 40 years or older
- Patients with Rutherford category 4 and 5
- Patients with angiographic evidence of infrapopliteal vessel occlusive disease
You will not qualify if you...
- Patients who refuse to participate in the study
- Patients with isolated proximal arterial disease (e.g. superficial femoral artery or popliteal artery) without infrapopliteal involvement
- Patients who develop acute thrombosis, flow limiting dissection, or perforation in the infrapopliteal arteries during intervention
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with follow-up through 6 months, with optional follow-up at 12 months
Participants undergo angioplasty of one, two, or three infrapopliteal arteries to restore blood flow to the ischemic area.
1 procedure visit and follow-up visits over 6 to 12 months
Trial Site Locations
Total: 1 location
1
Faculty of Medicine of Sohag
Sohag, Sohag Governorate, Egypt, 82511
Actively Recruiting
Research Team
M
Mahmoud Abdelrahman hafez, Master's student
M
Mahmoud El-saedy, MB BCh ( candidate )
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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