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

Aswan University

Status: Completed

Conditions: Critical Limb Ischemia; Tibialis Vessels Occlusion

Treatments: Procedure: Endovascular Revascularization

Study type: Interventional

Funder types: Other

Identifiers

NCT07383064

Asw.uni./980/9/24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Single tibial artery Endovascular Revascularization

Active Comparator group

Description:

Who undergo single tibial artery Endovascular Revascularization

Treatment:

Procedure: Endovascular Revascularization

Procedure: Endovascular Revascularization

Multiple tibialis vessels Endovascular Revascularization

Sham Comparator group

Description:

Who undergo more than one tibial artery Revascularization

Treatment:

Procedure: Endovascular Revascularization

Procedure: Endovascular Revascularization