Chronic Limb Threatening IschemiaNCT07068789
Revascularization of Single Vesrus Multiple Infrapopliteal Vessels in Chronic Limb Threatening Ischemia
A study testing balloon angioplasty in people with Chronic Limb Threatening Ischemia and Infrapopliteal Arterial Occlusive Disease, run by Sohag University at 1 site in Egypt.
Trial summary
This interventional prospective study aims to assess the effectiveness of single vessel versus multiple vessel infrapopliteal angioplasty in patients with chronic threatening limb ischemia . The study compares limb salvage rates and clinical outcomes across two groups over a defined follow up period Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Limb Threatening Ischemia, Infrapopliteal Arterial Occlusive Disease
- What is being tested?
- balloon angioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jun 2025to 25 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- patients who refuse to participate in the study
- patients with isolated proximal arterial disease (e.g SFA or popliteal ) without infrapopliteal involvement
- patients who develop acute thrombosis , flow limiting dissection or perforation in the infrapopliteal arteries during intervention -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mahmoud Abdelrahman hafez, Master's student contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine of Sohag
Sohag, Sohag Governorate, 82511
Mahmoud Elsaedy, master student, +0201060150246, lovezidan2011@yahoo.com
About this study
Official title: Revascularization of Single Versus Multiple Infrapopliteal Vesseles in Chronic Limb Threatening Ischemia : Limb Salvage Rate
This interventional prospective study aims to assess the effectiveness of single vessel versus multiple vessel infrapopliteal angioplasty in patients with chronic threatening limb ischemia . The study compares limb salvage rates and clinical outcomes across two groups over a defined follow up period
- Being tested
- balloon angioplasty
- Keywords
- chronic limb threatening ischemia, infrapopliteal arteries angioplasty, limb salvage, endovascular revascularization
- 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.
balloon angioplastyProcedure or surgery
endovascular angioplasty of infrapopliteal arteries performed using standard balloon catheters under fluroscopic guidance to restore blood flow to the ischemic area
| Study group | Role | What they receive |
|---|---|---|
| three vessel revascularization | Experimental | patients in this group will undergo will receive angioplasty of all three infrapopliteal arteries Receives: Procedure: balloon angioplasty |
| two vessel revascularization | Experimental | patients in this group will undergo will receive angioplasty of two infrapopliteal arteries Receives: Procedure: balloon angioplasty |
| single vessel revascularization | Experimental | patients in this group will undergo will receive angioplasty of only one infrapopliteal artery Receives: Procedure: balloon angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
limb salvage rate
percentage of patients who remain free from major lower limb amputation during the period of follow up after angioplasty
Measured: 6 months ( with optional follow up at 12 months )
limb salvage rate
percentage of patients who avoid major amputation during the period of follow up following angioplasty procedure
Measured: 6 months ( with optional follow up at 12 months )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start25 Jun 2025
- Primary completion25 Aug 2025 (estimated)
- Study completion25 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Limb Threatening IschemiaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to one of two parallel groups based on the revascularization strategy received : single vessel infrapopliteal angioplasty or multiple vessel infrapoplital angioplasty . Each participant will remain in the same intervention group throughout the study period and outcomes will be comapred between the two groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdelrahman Hafez, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068789
- Sponsor's protocol ID
- Soh-Med-25-6-14MS
- Status last verified
- Jun 2025
- First submitted
- 7 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not applicable data will be used internally for academic purpose only
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revascularization of Single Versus Multiple Infrapopliteal Vesseles in Chronic Limb Threatening Ischemia : Limb Salvage Rate
- ClinicalTrials.gov ID
- NCT07068789
- Acronym / sponsor ID
- Soh-Med-25-6-14MS
- Keywords
- chronic limb threatening ischemia, infrapopliteal arteries angioplasty, limb salvage, endovascular revascularization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 25 Aug 2025 (estimated)
- Study completion
- 25 Sep 2025 (estimated)
- First posted
- 16 Jul 2025 (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 interventional prospective study aims to assess the effectiveness of single vessel versus multiple vessel infrapopliteal angioplasty in patients with chronic threatening limb ischemia . The study compares limb salvage rates and clinical outcomes across two groups over a defined follow up period
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be assigned to one of two parallel groups based on the revascularization strategy received : single vessel infrapopliteal angioplasty or multiple vessel infrapoplital angioplasty . Each participant will remain in the same intervention group throughout the study period and outcomes will be comapred between the two groups
| Arm | Type | Receives |
|---|---|---|
| three vessel revascularization | Experimental | Procedure: balloon angioplastypatients in this group will undergo will receive angioplasty of all three infrapopliteal arteries |
| two vessel revascularization | Experimental | Procedure: balloon angioplastypatients in this group will undergo will receive angioplasty of two infrapopliteal arteries |
| single vessel revascularization | Experimental | Procedure: balloon angioplastypatients in this group will undergo will receive angioplasty of only one infrapopliteal artery |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- patients who refuse to participate in the study
- patients with isolated proximal arterial disease (e.g SFA or popliteal ) without infrapopliteal involvement
- patients who develop acute thrombosis , flow limiting dissection or perforation in the infrapopliteal arteries during intervention -
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 |
|---|---|---|
| balloon angioplastyendovascular angioplasty of infrapopliteal arteries performed using standard balloon catheters under fluroscopic guidance to restore blood flow to the ischemic area | Procedure or surgery | single vessel revascularization, three vessel revascularization, two vessel revascularization |
Primary outcome
limb salvage rate
Time frame: 6 months ( with optional follow up at 12 months )
percentage of patients who remain free from major lower limb amputation during the period of follow up after angioplasty
limb salvage rate
Time frame: 6 months ( with optional follow up at 12 months )
percentage of patients who avoid major amputation during the period of follow up following angioplasty procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: No. not applicable data will be used internally for academic purpose only
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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.
Mahmoud Abdelrahman hafez, Master's student contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing balloon angioplasty in people with Chronic Limb Threatening Ischemia and Infrapopliteal Arterial Occlusive Disease, run by Sohag 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 0 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 16 Jul 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Abdelrahman hafez, Master's student (+0201060150246, mahmoud.abdelrahmaan@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
limb salvage rate (time frame: 6 months ( with optional follow up at 12 months )). The study lists 2 primary outcomes in all. 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 16 Jul 2025.