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Revascularization of Single Vesrus Multiple Infrapopliteal Vessels in Chronic Limb Threatening Ischemia

S

Sohag University

Status

Enrolling

Conditions

Chronic Limb Threatening Ischemia
Infrapopliteal Arterial Occlusive Disease

Treatments

Procedure: balloon angioplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT07068789
Soh-Med-25-6-14MS

Details and patient eligibility

About

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

Enrollment

40 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion and 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 -

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 3 patient groups

three vessel revascularization
Experimental group
Description:
patients in this group will undergo will receive angioplasty of all three infrapopliteal arteries
Treatment:
Procedure: balloon angioplasty
two vessel revascularization
Experimental group
Description:
patients in this group will undergo will receive angioplasty of two infrapopliteal arteries
Treatment:
Procedure: balloon angioplasty
single vessel revascularization
Experimental group
Description:
patients in this group will undergo will receive angioplasty of only one infrapopliteal artery
Treatment:
Procedure: balloon angioplasty

Trial contacts and locations

1

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Central trial contact

Mahmoud Abdelrahman hafez, Master's student; Mahmoud El-saedy, MB BCh ( candidate )

Data sourced from clinicaltrials.gov

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