Lower Limb IschemiaNCT05569369
Endovascular Management of Combined Common Femoral and Superficial Femoral Arteries Lesions
A study testing angioplasty and stenting in people with Lower Limb Ischemia, run by Sohag University.
Trial summary
The purpose of this study is to evaluate the technical feasibility, safety, and 1-year clinical efficacy of the endovascular treatment of patients with atherosclerotic common femoral artery (CFA) obstructions with associated superficial femoral artery lesions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lower Limb Ischemia
- What is being tested?
- angioplasty and stenting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Nov 2022to Apr 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Serum creatinine < 2.
- Complaining of chronic lower limb threatening ischemia due to denovo atherosclerotic disease i.e. no previous intervention of common femoral artery with associated superficial femoral artery lesion (Rutherford stages 2-5).
Who cannot join
- - Non-atherosclerotic conditions (for example: vasculitis, collagen vascular disease, Buerger's disease, radiation).
- Acute limb ischemia.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Endovascular Management of Combined Common Femoral and Superficial Femoral Arteries Lesions in Patients With Chronic Lower Limb Threatening Ischemia
The purpose of this study is to evaluate the technical feasibility, safety, and 1-year clinical efficacy of the endovascular treatment of patients with atherosclerotic common femoral artery (CFA) obstructions with associated superficial femoral artery lesions. Participants will undergo angioplasty with or without stenting of common femoral and superficial femoral arteries.
Read the detailed description
Study design:
It is a prospective study which will include patients who need revascularization after approval of this study from local ethical committee and obtaining written informed consent.
Study setting:
This study will be done in Sohag University Hospitals and in Cairo University Hospitals.
Study sample:
This study will include 25 patients who present with chronic lower limb threatening ischemia and need endovascular revascularization and met the eligible criteria.
All patients in the study are subjected to the following: - (A) History
Complete history taking from all patients with special concern of the following:
- Age, sex and life style.
- History of diabetes, hypertension, dyslipidemia, stroke and coronary artery disease.
- History of smoking, congestive heart failure and chronic renal disease.
- History of blood diseases and hypercoagulable states.
- History of local or systemic infection.
- History of previous revascularization in the same limb and the other limbs. (B)Examination
General examination:
- General condition.
- Vital signs: - (pulse, blood pressure, temperature, respiration).
- Systemic examination and preoperative medical assessment especially cardiopulmonary and renal systems evaluation.
Local examination:
- Examination of the arterial pulsation all over the arterial tree.
- Measuring ankle brachial index (ABI) and toe brachial index (TBI).
- Examination of any wound and measuring its dimensions. (c) Investigation Including: _
- Complete blood count, lipid profile, fasting blood sugar and HgA1C.
- Bleeding time and coagulation time.
- Prothrombin time and concentration, serum urea and creatinine.
- Echocardiography and ECG.
- Arterial duplex of the affected limb.
- CT angiography of abdominal aorta and both lower limbs unless creatinine clearance (CrCl) is impaired (D) Procedure All procedures will be performed in the operating room by vascular surgeons. Local anesthesia with conscious sedation is indicated, unless general anesthesia is needed in patients who are restless and in pain.
Access to the lesion is achieved either by way of an over-the-aortic bifurcation approach with the use of a dedicated 6-F or 7-F-long sheath (45 cm) or via a brachial approach with the use of a dedicated 6-F or 7-F-long sheath (90 cm) or retrograde via popliteal approach if failed antegrade approach.
After sheath placement, an intravenous bolus of 50 UI kg-1 of heparin is given. Digital subtraction angiography (DSA) is performed to assess lesions. After successful passage of the target lesions with a hydrophilic 0.035-inch guide wire, primary stenting without lesion pre-dilatation is preferably performed. One stenting technique from the CFA to the superficial femoral artery (SFA) may be involved.
The last generation of self-expandable stents eg The Supera stent will be used in common femoral artery lesions.
Balloon-expandable stents are used for associated SFA lesions. Self-expandable stents are routinely post-dilated. The balloon dimensions are chosen such that the nominal diameter is inferior to the stent diameter by 1 mm to reduce medial damage and the length doesn't exceed the stent length. The technical result of the procedure is assessed by DSA.
A prophylactic dose of low-molecular-weight heparin is given during the duration of hospitalization to prevent venous thrombo-embolic events. Postoperatively, patients are prescribed aspirin (75-160 mg day-1) and clopidogrel (75 mg day-1) for 6 months. After 6 months, patients are prescribed only clopidogrel (75 mg day-1).
- Conditions
- Lower Limb Ischemia
- Being tested
- angioplasty and stenting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
angioplasty and stentingProcedure or surgery
Also called atherectomy
dilatation of stenotic arteries and insertion of stent
| Study group | Role | What they receive |
|---|---|---|
| angioplasty with stenting | Experimental | Not described Receives: Procedure: angioplasty and stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
sustained clinical improvement.
a sustained upward shift of ≥1 category of the Rutherford classification without the need for repeated target lesion revascularization in surviving patients.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study startNov 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Eldin AHmed Soliman, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569369
- Sponsor's protocol ID
- Soh-Med-22-07-23
- Status last verified
- Oct 2022
- First submitted
- 4 Oct 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Management of Combined Common Femoral and Superficial Femoral Arteries Lesions in Patients With Chronic Lower Limb Threatening Ischemia
- ClinicalTrials.gov ID
- NCT05569369
- Acronym / sponsor ID
- Soh-Med-22-07-23
- Conditions
- Lower Limb Ischemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 6 Oct 2022 (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.
The purpose of this study is to evaluate the technical feasibility, safety, and 1-year clinical efficacy of the endovascular treatment of patients with atherosclerotic common femoral artery (CFA) obstructions with associated superficial femoral artery lesions. Participants will undergo angioplasty with or without stenting of common femoral and superficial femoral arteries.
Detailed description
Study design:
It is a prospective study which will include patients who need revascularization after approval of this study from local ethical committee and obtaining written informed consent.
Study setting:
This study will be done in Sohag University Hospitals and in Cairo University Hospitals.
Study sample:
This study will include 25 patients who present with chronic lower limb threatening ischemia and need endovascular revascularization and met the eligible criteria.
All patients in the study are subjected to the following: - (A) History
Complete history taking from all patients with special concern of the following:
- Age, sex and life style.
- History of diabetes, hypertension, dyslipidemia, stroke and coronary artery disease.
- History of smoking, congestive heart failure and chronic renal disease.
- History of blood diseases and hypercoagulable states.
- History of local or systemic infection.
- History of previous revascularization in the same limb and the other limbs. (B)Examination
General examination:
- General condition.
- Vital signs: - (pulse, blood pressure, temperature, respiration).
- Systemic examination and preoperative medical assessment especially cardiopulmonary and renal systems evaluation.
Local examination:
- Examination of the arterial pulsation all over the arterial tree.
- Measuring ankle brachial index (ABI) and toe brachial index (TBI).
- Examination of any wound and measuring its dimensions. (c) Investigation Including: _
- Complete blood count, lipid profile, fasting blood sugar and HgA1C.
- Bleeding time and coagulation time.
- Prothrombin time and concentration, serum urea and creatinine.
- Echocardiography and ECG.
- Arterial duplex of the affected limb.
- CT angiography of abdominal aorta and both lower limbs unless creatinine clearance (CrCl) is impaired (D) Procedure All procedures will be performed in the operating room by vascular surgeons. Local anesthesia with conscious sedation is indicated, unless general anesthesia is needed in patients who are restless and in pain.
Access to the lesion is achieved either by way of an over-the-aortic bifurcation approach with the use of a dedicated 6-F or 7-F-long sheath (45 cm) or via a brachial approach with the use of a dedicated 6-F or 7-F-long sheath (90 cm) or retrograde via popliteal approach if failed antegrade approach.
After sheath placement, an intravenous bolus of 50 UI kg-1 of heparin is given. Digital subtraction angiography (DSA) is performed to assess lesions. After successful passage of the target lesions with a hydrophilic 0.035-inch guide wire, primary stenting without lesion pre-dilatation is preferably performed. One stenting technique from the CFA to the superficial femoral artery (SFA) may be involved.
The last generation of self-expandable stents eg The Supera stent will be used in common femoral artery lesions.
Balloon-expandable stents are used for associated SFA lesions. Self-expandable stents are routinely post-dilated. The balloon dimensions are chosen such that the nominal diameter is inferior to the stent diameter by 1 mm to reduce medial damage and the length doesn't exceed the stent length. The technical result of the procedure is assessed by DSA.
A prophylactic dose of low-molecular-weight heparin is given during the duration of hospitalization to prevent venous thrombo-embolic events. Postoperatively, patients are prescribed aspirin (75-160 mg day-1) and clopidogrel (75 mg day-1) for 6 months. After 6 months, patients are prescribed only clopidogrel (75 mg day-1).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| angioplasty with stenting | Experimental | Procedure: angioplasty and stenting |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Serum creatinine < 2.
- Complaining of chronic lower limb threatening ischemia due to denovo atherosclerotic disease i.e. no previous intervention of common femoral artery with associated superficial femoral artery lesion (Rutherford stages 2-5).
Key exclusion criteria (2 listed)
- - Non-atherosclerotic conditions (for example: vasculitis, collagen vascular disease, Buerger's disease, radiation).
- Acute limb ischemia.
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 |
|---|---|---|
| angioplasty and stentingAlso: atherectomydilatation of stenotic arteries and insertion of stent | Procedure or surgery | angioplasty with stenting |
Primary outcome
sustained clinical improvement.
Time frame: 1 year
a sustained upward shift of ≥1 category of the Rutherford classification without the need for repeated target lesion revascularization in surviving patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing angioplasty and stenting in people with Lower Limb Ischemia, run by Sohag University.
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: status not confirmed, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hossam eldeen A soliman (0101045804, hossameldeen.mohamed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sustained clinical improvement. (time frame: 1 year). 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 6 Oct 2022.