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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07383064
Enrollment
40
Registered
2026-02-03
Start date
2025-01-01
Completion date
2025-12-09
Last updated
2026-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Limb Ischemia, Tibialis Vessels Occlusion

Keywords

Endovascular Revascularization for critical limb ischemia

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.

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.

Interventions

One would undergo single tibial artery Endovascular Revascularization

Sponsors

Aswan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Salvageable of limb(( patients don't need for major amputation )) sabe limb from major amputation2yearsSalvageable of limb

Countries

Egypt

Contacts

STUDY_CHAIRAli Mahmoud Galal, MD of vascular surgery

Aswan University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026