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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.
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:
General examination:
Local examination:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| angioplasty with stenting | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| angioplasty and stenting | Procedure | dilatation of stenotic arteries and insertion of stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| hossam eldeen A soliman | Contact | 0101045804 | hossameldeen.mohamed@med.sohag.edu.eg |
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| ID | Term |
|---|---|
| D017130 | Angioplasty |
| D015607 | Stents |
| D017073 | Atherectomy |
| ID | Term |
|---|---|
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
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| D013504 |
| Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |