Pilot Prospective Study of Two Methods of Revascularization of the Superficial Femoral Artery: Stenting in the Superficial Femoral Artery, and Stenting of the Superficial Femoral Artery, Supplemented by Fasciotomy in Hunter Channel in Patients With Steno-occlusive Lesions of Femoral-popliteal Segment TASC C, D
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Atherosclerosis of the Peripheral Artery
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Ankle-brachial index
- Last Updated
- 9 years ago
Overview
Brief Summary
Comparison of two methods for revascularization of the superficial femoral artery: stenting of the superficial femoral artery vs. stenting of the superficial femoral artery supplemented with fasciotomy in Hunter canal in patients with steno-occlusive lesion of the femoro-popliteal segment of TASC C, D.
Detailed Description
Physiological flexions and extensions in hip and knee joints cause dramatic deformity in stented femoral and superficial femoral arteries, both axially and angularly. As a result, stents get broken, restenosed or thrombosed. Some researchers report a 20 to 46% two-year incidence of broke stents in the superficial femoral artery, while restenosis and occlusion incidence vary from 21.8% to 53.3% . In addition to axial and angular stress, contributing to this untoward effect is musculofascial sheath which houses the artery in distal thigh. Investigators suggest that standard stenting of an artery be augmented by incision of the anterior musculofascial sheath (septum intermuscular vastoadductoria) that will increase the mobility of distal part of the femoral artery, which will decrease frequency breakage of stents. Review of the world literature yielded no peer instances of such improvement of stenting outcomes in the said arteries.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with occlusive lesions of C and D type iliac segment, and with chronic lower limb ischemia (II-IV degree by Fontaine, 4-6 degree by Rutherford).
- •Patients who consented to participate in this study.
Exclusion Criteria
- •Chronic heart failure of III-IV functional class by NYHA classification.
- •Decompensated chronic "pulmonary" heart
- •Severe hepatic or renal failure (bilirubin\> 35 mmol / l, glomerular filtration rate \<60 mL / min);
- •Polyvalent drug allergy
- •Cancer in the terminal stage with a life expectancy less than 6 months;
- •Acute ischemic
- •Expressed aortic calcification tolerant to angioplasty
- •Patients with significant common femoral artery lesion
- •Patient refusal to participate or continue to participate in the study
Outcomes
Primary Outcomes
Ankle-brachial index
Time Frame: Baseline, 3 days after the operation, 6 month, 12 month, 2 years
Change in ankle-brachial index.
Ultrasound scan of the operated segment
Time Frame: Baseline, 3 days after the operation, 6 month, 12 month, 2 years
The degree of stenosis in the operated segment.
CT-angiography of lower limb arteries
Time Frame: Baseline, 3 days after the operation, 6 month, 12 month, 2 years
The degree of stenosis in the operated segment. CT-angiography of lower limb arteries at the control points will be done only if the detection of steno-occlusive lesions of the operated segment during the observation period, confirmed by ultrasound.
Secondary Outcomes
- Number of participants with a successful procedure of revascularization.(During the operation.)
- Number of participants with complications during the operation.(During the operation.)
- Number of participants with limb salvage(3 days after the operation, 6 month, 12 month, 2 years)