Chronic Threatening Limb IschemiaNCT07239089
Oucomes of Endovascular Atherectomy in Femoropopliteal Arterial Disease
An observational study of Chronic Threatening Limb Ischemia, run by Assiut University at 1 site in Egypt.
Trial summary
Peripheral artery disease (PAD) affects >200 millionadults worldwide and is amajor cause of morbidity ranging from exertional lower extremity pain to ischemic rest pain and ulcer formation. Endovascular treatment options for PAD have increased dramatically in the past several decades. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Threatening Limb Ischemia
- What is being tested?
- Endovascular Atherectomy
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2025to 22 Oct 2027
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: the estimated minimum required sample size is 60 patients (30 in each group).
Who may be able to join
- All patients present with CLTI due to femoropopliteal artery disease with the following criteria:
- Denovo or Recoil
- Stenosis or occlusion
Who cannot join
- Patients present with:
- Previous ipsilateral bypass surgery
- In-stent restenosis or previous atherectomy
- Known hypercoagulable disorder or non-atherosclerotic vasculopathy
- Severe renal insufficiency (eGFR <30) not on dialysis
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Endovascular Atherectomy in Femoropopliteal Arterial Disease
Peripheral artery disease (PAD) affects >200 millionadults worldwide and is amajor cause of morbidity ranging from exertional lower extremity pain to ischemic rest pain and ulcer formation.
Endovascular treatment options for PAD have increased dramatically in the past several decades. The traditional endovascular treatment of severe PAD has been balloon angioplasty with or without adjunctive stenting.
Read more
The outcomes of balloon angioplasty and stenting are acceptable for short lesion lengths in the superficial femoral artery (SFA) and proximal popliteal arteries.Therefore, there is an established need for technologies that can adequately treat more complex femoropopliteal lesions.
Endovascular atherectomy has emerged as a novel technique for atheroma removal in patients with disease of the SFA or popliteal arteries. Atherectomy offers the advantages of surgical endarterectomy by removing atherosclerotic plaque while remaining a minimally invasive and percutaneous treatment.
- Conditions
- Chronic Threatening Limb Ischemia
- Being tested
- Endovascular Atherectomy
- 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 AtherectomyDevice
Endovascular Atherectomy in femoropopliteal arterial disease
| Study group | Role | What they receive |
|---|---|---|
| sample size is 60 patients (30 in each group). | Not described Receives: Device: Endovascular Atherectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
completion of the endovascular procedure without the need for further intervention for revascularization and an absence of substantial or complete occlusion in SFA at final angiography.
Measured: From october 2025 to october 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Oct 2025
- Primary completion22 Oct 2026 (estimated)
- Study completion22 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Threatening Limb IschemiaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hassan Ahmed Mohamed Elshimy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239089
- Sponsor's protocol ID
- AssiutU
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Endovascular Atherectomy in Femoropopliteal Arterial Disease
- ClinicalTrials.gov ID
- NCT07239089
- Acronym / sponsor ID
- AssiutU
- Conditions
- Chronic Threatening Limb Ischemia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 22 Oct 2026 (estimated)
- Study completion
- 22 Oct 2027 (estimated)
- First posted
- 20 Nov 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.
Peripheral artery disease (PAD) affects >200 millionadults worldwide and is amajor cause of morbidity ranging from exertional lower extremity pain to ischemic rest pain and ulcer formation.
Endovascular treatment options for PAD have increased dramatically in the past several decades. The traditional endovascular treatment of severe PAD has been balloon angioplasty with or without adjunctive stenting.
The outcomes of balloon angioplasty and stenting are acceptable for short lesion lengths in the superficial femoral artery (SFA) and proximal popliteal arteries.Therefore, there is an established need for technologies that can adequately treat more complex femoropopliteal lesions.
Endovascular atherectomy has emerged as a novel technique for atheroma removal in patients with disease of the SFA or popliteal arteries. Atherectomy offers the advantages of surgical endarterectomy by removing atherosclerotic plaque while remaining a minimally invasive and percutaneous treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sample size is 60 patients (30 in each group). | – | Device: Endovascular Atherectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- the estimated minimum required sample size is 60 patients (30 in each group).
Key inclusion criteria (3 listed)
- All patients present with CLTI due to femoropopliteal artery disease with the following criteria:
Key exclusion criteria (6 listed)
- Patients present with:
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 AtherectomyEndovascular Atherectomy in femoropopliteal arterial disease | Device | sample size is 60 patients (30 in each group). |
Primary outcome
Technical success
Time frame: From october 2025 to october 2027
completion of the endovascular procedure without the need for further intervention for revascularization and an absence of substantial or complete occlusion in SFA at final angiography.
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 20 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Threatening Limb Ischemia, run by Assiut 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 3 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 20 Nov 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?
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?
Technical success (time frame: From october 2025 to october 2027). 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 20 Nov 2025.