search
Back to results

Endovascular Management of Combined Common Femoral and Superficial Femoral Arteries Lesions

Primary Purpose

Lower Limb Ischemia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
angioplasty and stenting
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Limb Ischemia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • - Non-atherosclerotic conditions (for example: vasculitis, collagen vascular disease, Buerger's disease, radiation).
  • Acute limb ischemia.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    angioplasty with stenting

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 4, 2022
    Last Updated
    October 4, 2022
    Sponsor
    Sohag University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05569369
    Brief Title
    Endovascular Management of Combined Common Femoral and Superficial Femoral Arteries Lesions
    Official Title
    Endovascular Management of Combined Common Femoral and Superficial Femoral Arteries Lesions in Patients With Chronic Lower Limb Threatening Ischemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2022 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    April 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sohag University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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. 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lower Limb Ischemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    25 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    angioplasty with stenting
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    angioplasty and stenting
    Other Intervention Name(s)
    atherectomy
    Intervention Description
    dilatation of stenotic arteries and insertion of stent
    Primary Outcome Measure Information:
    Title
    sustained clinical improvement.
    Description
    a sustained upward shift of ≥1 category of the Rutherford classification without the need for repeated target lesion revascularization in surviving patients.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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). Exclusion Criteria: - Non-atherosclerotic conditions (for example: vasculitis, collagen vascular disease, Buerger's disease, radiation). Acute limb ischemia.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    hossam eldeen A soliman
    Phone
    0101045804
    Email
    hossameldeen.mohamed@med.sohag.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Endovascular Management of Combined Common Femoral and Superficial Femoral Arteries Lesions

    We'll reach out to this number within 24 hrs