Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05569369 |
| Other study ID # |
Soh-Med-22-07-23 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 2022 |
| Est. completion date |
April 2024 |
Study information
| Verified date |
October 2022 |
| Source |
Sohag University |
| Contact |
hossam eldeen A soliman |
| Phone |
0101045804 |
| Email |
hossameldeen.mohamed[@]med.sohag.edu.eg |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
Participants will undergo angioplasty with or without stenting of common femoral and
superficial femoral arteries.
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).
