Single Versus Multiple Vessels Endovascular Tibial Arteries Revascularization for Critical Limb Ischemia

NCT07383064 | Completed DMC

• 1 other identifier: Asw.uni./980/9/24
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to Compare the outcomes of angioplasty for single tibial vessel occlusion versus multiple tibial vessel occlusions in patients with critical limb ischemia. Assess the effectiveness and safety of angioplasty in treating different extents of tibial vessel occlusions. Evaluate the impact of angioplasty on limb salvage rates, healing of ischemic wounds, and overall clinical improvement in patients with CLI.

Conditions

Critical Limb Ischemia; Tibialis Vessels Occlusion

Keywords

Endovascular Revascularization for critical limb ischemia

Outcome Measures

Primary Outcomes (1)

• Salvageable of limb(( patients don't need for major amputation )) sabe limb from major amputation

  Salvageable of limb

  2years

Study Arms (2)

Single tibial artery Endovascular Revascularization

ACTIVE COMPARATOR

Who undergo single tibial artery Endovascular Revascularization

Procedure: Endovascular Revascularization

Multiple tibialis vessels Endovascular Revascularization

SHAM COMPARATOR

Who undergo more than one tibial artery Revascularization

Procedure: Endovascular Revascularization

Interventions

Endovascular Revascularization PROCEDURE

One would undergo single tibial artery Endovascular Revascularization

Also known as: Endovascular

Multiple tibialis vessels Endovascular Revascularization; Single tibial artery Endovascular Revascularization

Eligibility Criteria

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

You may qualify if:

• Patients with:
• Rutherford Class 5 and 6 Single or multiple occlusive infrapopliteal vessel lesions In-flow vessel (superficial femoral artery and popliteal artery) free from flow-limiting lesion or in-flow lesion correction with bypass or endovascular intervention during index procedure.

You may not qualify if:

• Patients with:
• Prior vascular intervention in target limb Technical/hemodynamic failure inflow occlusive disease. Patient with allergy to the contrast

Sponsors & Collaborators

• Aswan University: lead

Study Sites (1)

Aswan university hospitals

Aswān, Aswan Governorate, 81511, Egypt

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

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

Study Officials

• Ali Mahmoud Galal, MD of vascular surgery

  Aswan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular surgery resident

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: February 3, 2026
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 9, 2025
• Last Updated: February 3, 2026

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

EG (1)