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

NCT07068789 | Recruiting

• 1 other identifier: Soh-Med-25-6-14MS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Limb Threatening Ischemia; Infrapopliteal Arterial Occlusive Disease

Keywords

chronic limb threatening ischemia; infrapopliteal arteries angioplasty; limb salvage; endovascular revascularization

Outcome Measures

Primary Outcomes (2)

• limb salvage rate

  percentage of patients who remain free from major lower limb amputation during the period of follow up after angioplasty

  6 months ( with optional follow up at 12 months )

• limb salvage rate

  percentage of patients who avoid major amputation during the period of follow up following angioplasty procedure

  6 months ( with optional follow up at 12 months )

Study Arms (3)

three vessel revascularization

EXPERIMENTAL

patients in this group will undergo will receive angioplasty of all three infrapopliteal arteries

Procedure: balloon angioplasty

two vessel revascularization

EXPERIMENTAL

patients in this group will undergo will receive angioplasty of two infrapopliteal arteries

Procedure: balloon angioplasty

single vessel revascularization

EXPERIMENTAL

patients in this group will undergo will receive angioplasty of only one infrapopliteal artery

Procedure: balloon angioplasty

Interventions

balloon angioplasty PROCEDURE

endovascular angioplasty of infrapopliteal arteries performed using standard balloon catheters under fluroscopic guidance to restore blood flow to the ischemic area

single vessel revascularization; three vessel revascularization; two vessel revascularization

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• patients who refuse to participate in the study
• patients with isolated proximal arterial disease (e.g SFA or popliteal ) without infrapopliteal involvement
• patients who develop acute thrombosis , flow limiting dissection or perforation in the infrapopliteal arteries during intervention -

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Faculty of Medicine of Sohag

Sohag, Sohag Governorate, 82511, Egypt

RECRUITING

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Interventions

Angioplasty, Balloon

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Central Study Contacts

Mahmoud Abdelrahman hafez, Master's student

CONTACT

+0201060150246; mahmoud.abdelrahmaan@med.sohag.edu.eg

Mahmoud El-saedy, MB BCh ( candidate )

CONTACT

+0201120908609; elsaedymahmoud13@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mahmoud Abdelrahman Hafez

Model Details: 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

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 16, 2025
• Study Start: June 25, 2025
• Primary Completion: August 25, 2025
• Study Completion: September 25, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)