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CompletedNCT07383064Updated Feb 3, 2026

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

An interventional study of Endovascular Revascularization and Endovascular Revascularization in Critical Limb Ischemia and Tibialis Vessels Occlusion, sponsored by Aswan University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-03.

Sponsored by Aswan University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jan 2025, registered Jan 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Critical Limb Ischemia
  • Tibialis Vessels Occlusion

Keywords

  • Endovascular Revascularization for critical limb ischemia
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In context

Chronic Limb-Threatening Ischemia

343 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 70 are open to participants now.

This study's enrollment of 40 is below the median of 45 across 233 interventional studies indexed under Chronic Limb-Threatening Ischemia.

Browse Chronic Limb-Threatening Ischemia studies →

Lead sponsor

Aswan University is the lead sponsor of 47 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Patients with:

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Single tibial artery Endovascular Revascularization

    Who undergo single tibial artery Endovascular Revascularization

    Procedure: Endovascular Revascularization

  • Sham comparator
    Multiple tibialis vessels Endovascular Revascularization

    Who undergo more than one tibial artery Revascularization

    Procedure: Endovascular Revascularization

Interventions

  • ProcedureEndovascular Revascularization

    One would undergo single tibial artery Endovascular Revascularization

    Also known as: Endovascular

  • ProcedureEndovascular Revascularization

    Other would undergo multiple tibialis vessels Endovascular Revascularization

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What researchers measure

Primary outcomes

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

    Salvageable of limb

    Time frame: 2years

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Study locations

1 site
  • Aswan university hospitals
    Aswān, Aswan Governorate 81511, Egypt
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References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07383064
Lead sponsor
Aswan University
Responsible party
Mohammed Zakria Mohammed El Amir (Vascular surgery resident, Aswan University) — Principal investigator
First posted
Feb 3, 2026
Start date
Jan 1, 2025
Primary completion
Dec 1, 2025
Completion
Dec 9, 2025
Last update
Feb 3, 2026

Study contacts

Ali Mahmoud Galal, MD of vascular surgery
study chair · Aswan University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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