Opening one versus multiple below-knee arteries to save legs in severe chronic limb-threatening ischemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Esprit BTK everolimus-eluting resorbable scaffold in infrapopliteal artery disease for CLTI

  This study tests whether the Esprit BTK Everolimus Eluting Resorbable Scaffold works in real-world patients with chronic limb-threatening ischemia and heavily calcified infrapopliteal arteries.

  Recruiting Cardiovascular and Interventional Radiological Society of Europe · Hull · NCT07270575

• Orbital Atherectomy to Prep Calcified Leg Arteries in CLTI Patients

  This Europe-wide study tests how well orbital atherectomy helps patients with chronic limb-threatening ischemia when opening heavily calcified leg arteries.

  Recruiting Cardiovascular and Interventional Radiological Society of Europe · Hull · NCT07270562

• Predictors of Major Adverse Limb Events After Iliac Artery Stenting

  This study tests what factors predict serious limb-related problems after iliac artery stenting in adults with peripheral artery disease.

  Recruiting I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Milan, Mi · NCT07672249

• Colchicine for people with severe limb-threatening leg artery disease

  A low-dose colchicine pill is being tested to see if it can help people with chronic limb-threatening ischemia avoid worsening of their leg condition and improve outcomes.

  Recruiting at 2 sites Phase 3 Shin Kong Wu Ho-Su Memorial Hospital · Taipei, Taipei and 4 other locations · NCT07536373

• Imaging plaque activity across the body in people with symptomatic peripheral arterial disease

  This project will use whole-body PET-CT and CT angiography with several tracers to see if imaging can detect inflammation, microcalcification, and clot activity in people with symptomatic peripheral arterial disease.

  Recruiting University of Edinburgh · Edinburgh, Midlothian · NCT07472049

• Vessel recoil after below-the-knee revascularization in high-risk CLTI patients

  This study tests how much vessels recoil after a final endovascular treatment in adults with chronic limb-threatening ischemia affecting below-the-knee arteries.

  Recruiting Medical University of Graz · Graz · NCT07465627

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.