Opening one versus multiple below-knee arteries to save legs in severe chronic limb-threatening ischemia
Revascularization of Single Versus Multiple Infrapopliteal Vesseles in Chronic Limb Threatening Ischemia : Limb Salvage Rate
This trial will test whether opening a single below‑knee artery or opening multiple below‑knee arteries with balloon angioplasty better preserves the leg in people aged 40+ with severe chronic limb‑threatening ischemia (Rutherford 4–5).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Sohag University Academic / other |
| Locations | 1 site (Sohag, Sohag Governorate) |
| Trial ID | NCT07068789 on ClinicalTrials.gov |
What this trial studies
This is a prospective interventional study comparing two endovascular strategies — single‑vessel versus multi‑vessel infrapopliteal balloon angioplasty — in patients with chronic limb‑threatening ischemia. Participants who meet angiographic criteria and are Rutherford category 4 or 5 will be assigned to one of the two revascularization approaches and followed over a defined postprocedure period. The primary comparisons will focus on limb salvage rates and clinical outcomes after the interventions. The trial is conducted at the Faculty of Medicine of Sohag and excludes patients with isolated proximal (SFA or popliteal) disease, procedural complications like acute thrombosis, or those who decline participation.
Who should consider this trial
Good fit: People aged 40 or older with angiographic infrapopliteal occlusive disease and Rutherford category 4 or 5 who are candidates for balloon angioplasty.
Not a fit: Patients with disease confined to the superficial femoral or popliteal arteries, those who develop acute thrombosis or major procedural complications, or those who refuse participation are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the results could help clinicians choose the angioplasty approach most likely to improve limb salvage and reduce amputations.
How similar studies have performed: Previous endovascular studies show infrapopliteal angioplasty can improve limb salvage, but direct comparisons of single‑ versus multi‑vessel below‑knee revascularization are limited and have shown mixed results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 -
Where this trial is running
Sohag, Sohag Governorate
- Faculty of Medicine of Sohag — Sohag, Sohag Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Mahmoud Abdelrahman hafez, Master's student
- Email: mahmoud.abdelrahmaan@med.sohag.edu.eg
- Phone: +0201060150246
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.