Critical Limb IschemiaNCT07383064
Single Versus Multiple Vessels Endovascular Tibial Arteries Revascularization for Critical Limb Ischemia
A study testing Endovascular Revascularization in people with Critical Limb Ischemia and Tibialis Vessels Occlusion, run by Aswan University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Limb Ischemia, Tibialis Vessels Occlusion
- What is being tested?
- Endovascular Revascularization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 9 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with:
- Prior vascular intervention in target limb Technical/hemodynamic failure inflow occlusive disease. Patient with allergy to the contrast
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Critical Limb Ischemia, Tibialis Vessels Occlusion
- Being tested
- Endovascular Revascularization
- Keywords
- Endovascular Revascularization for critical limb ischemia
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular RevascularizationProcedure or surgery
Also called Endovascular
One would undergo single tibial artery Endovascular Revascularization
Endovascular RevascularizationProcedure or surgery
Other would undergo multiple tibialis vessels Endovascular Revascularization
| Study group | Role | What they receive |
|---|---|---|
| Single tibial artery Endovascular Revascularization | Active comparator | Who undergo single tibial artery Endovascular Revascularization Receives: Procedure: Endovascular Revascularization |
| Multiple tibialis vessels Endovascular Revascularization | Sham comparator | Who undergo more than one tibial artery Revascularization Receives: Procedure: Endovascular Revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salvageable of limb(( patients don't need for major amputation )) sabe limb from major amputation
Salvageable of limb
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Jan 2025
- Primary completion1 Dec 2025
- Study completion9 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Zakria Mohammed El Amir, Aswan University
- Investigators
- Ali Mahmoud Galal, MD of vascular surgery, Study chair, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383064
- Sponsor's protocol ID
- Asw.uni./980/9/24
- Status last verified
- Dec 2024
- First submitted
- 16 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Versus Multiple Vessels Endovascular Tibial Arteries Revascularization for Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT07383064
- Acronym / sponsor ID
- Asw.uni./980/9/24
- Conditions
- Critical Limb Ischemia, Tibialis Vessels Occlusion
- Keywords
- Endovascular Revascularization for critical limb ischemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 9 Dec 2025 (actual)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single tibial artery Endovascular Revascularization | Active comparator | Procedure: Endovascular RevascularizationWho undergo single tibial artery Endovascular Revascularization |
| Multiple tibialis vessels Endovascular Revascularization | Sham comparator | Procedure: Endovascular RevascularizationWho undergo more than one tibial artery Revascularization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with:
- Prior vascular intervention in target limb Technical/hemodynamic failure inflow occlusive disease. Patient with allergy to the contrast
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular RevascularizationAlso: EndovascularOne would undergo single tibial artery Endovascular Revascularization | Procedure or surgery | Multiple tibialis vessels Endovascular Revascularization, Single tibial artery Endovascular Revascularization |
| Endovascular RevascularizationOther would undergo multiple tibialis vessels Endovascular Revascularization | Procedure or surgery | Multiple tibialis vessels Endovascular Revascularization, Single tibial artery Endovascular Revascularization |
Primary outcome
Salvageable of limb(( patients don't need for major amputation )) sabe limb from major amputation
Time frame: 2years
Salvageable of limb
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Mahmoud Galal, MD of vascular surgery study chair
Aswan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular Revascularization in people with Critical Limb Ischemia and Tibialis Vessels Occlusion, run by Aswan University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salvageable of limb(( patients don't need for major amputation )) sabe limb from major amputation (time frame: 2years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.