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

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.

Study Overview

• Status: Completed
• Conditions: Critical Limb Ischemia; Tibialis Vessels Occlusion
• Intervention / Treatment: Procedure: Endovascular Revascularization; Procedure: Endovascular Revascularization

Detailed Description

This study demonstrates that in patients with chronic limb-threatening ischemia (CLTI), revascularization resulting in the patency of multiple tibial vessels is associated with significantly superior clinical outcomes compared to single-vessel patency. While both strategies were equally safe and technically feasible, the multiple-tibial-vessel (MTV) group achieved perfect limb salvage, higher primary patency, lower restenosis rates, and significantly better wound healing at six months. These findings underscore the importance of robust tibial runoff, supporting the "angiogenic reserve" concept where multiple patent vessels provide redundant perfusion pathways that enhance the durability of revascularization and promote tissue repair. Consequently, when anatomically feasible, treatment strategies should prioritize the establishment or preservation of multi-vessel tibial outflow to optimize limb salvage and functional recovery in this high-risk population.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Aswan Governorate
    • Aswān, Aswan Governorate, Egypt, 81511
      • Aswan university hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients with:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single tibial artery Endovascular Revascularization; Who undergo single tibial artery Endovascular Revascularization	Procedure: Endovascular Revascularization; One would undergo single tibial artery Endovascular Revascularization; Other Names: Endovascular; Procedure: Endovascular Revascularization; Other would undergo multiple tibialis vessels Endovascular Revascularization
Sham Comparator: Multiple tibialis vessels Endovascular Revascularization; Who undergo more than one tibial artery Revascularization	Procedure: Endovascular Revascularization; One would undergo single tibial artery Endovascular Revascularization; Other Names: Endovascular; Procedure: Endovascular Revascularization; Other would undergo multiple tibialis vessels Endovascular Revascularization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salvageable of limb(( patients don't need for major amputation )) sabe limb from major amputation	Salvageable of limb	2years

Collaborators and Investigators

• Sponsor: Aswan University
• Investigators: Study Chair: Ali Mahmoud Galal, MD of vascular surgery, Aswan University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): December 1, 2025
• Study Completion (Actual): December 9, 2025

Study Registration Dates

• First Submitted: January 16, 2026
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): February 3, 2026

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Endovascular Revascularization for critical limb ischemia
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Ischemia; Peripheral Arterial Disease; Pathological Conditions, Signs and Symptoms; Chronic Limb-Threatening Ischemia
• Other Study ID Numbers: Asw.uni./980/9/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes