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
About this trial
This is an interventional treatment trial for Lower Limb Ischemia
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.
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
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
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