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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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).

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 groups in NCT05569369
Study groupRoleWhat they receive
angioplasty with stentingExperimentalNot described
Receives: Procedure: angioplasty and stenting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted6 Oct 2022
  2. Study startNov 2022 (estimated)
  3. Primary completionDec 2023 (estimated)
  4. Study completionApr 2024 (estimated)

Resources

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)
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

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.

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