Pilot Prospective Study of Two Methods of Revascularization of the Femoral Artery (SFA): Stenting in the SFA, and Stenting of the SFA, Supplemented by Fasciotomy in Hunter Channel.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Stenting of the femoral artery. A standard endovascular exposure is carried out under local anesthesia and a lesioned arterial segment is visualized. Stenosis or artery occlusion is passed by the hydrophilic guide. During the occlusion transluminal or subintimal artery recanalization (most frequently mixed) is conduced. Then balloon angioplasty of stenosis or occlusion are carried out. After the angiographic control if necessary stent of all the extension is mounted. |
Procedure: Angioplasty with stenting of the femoral artery
A standard endovascular exposure is carried out under local anesthesia and a lesioned arterial segment is visualized. Stenosis or artery occlusion is passed by the hydrophilic guide. During the occlusion transluminal or subintimal artery recanalization (most frequently mixed) is conduced. Then balloon angioplasty of stenosis or occlusion are carried out. After the angiographic control if necessary stent (balloon extpandable or self-expanding) of all the extension is mounted.
Medical therapy includes aspirin (acid acetylsalicylic) prescription before the procedure (160 - 300 mg/d), beginning from minimum per day and heparin (heparin sodium) injection during the procedure (5000 U iv). After the procedure aspirin (acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and plavix (clopidogrel) in dose 75/d should be prescribed within 3 months.
|
| Experimental: Stenting of the femoral artery and fasciotomy. Under local anesthesia standard endovascular exposure is made and lesioned arterial segment is visualized. Stenosis or artery occlusion is passed by the hydrophilic guide. During the occlusion transluminal or subintimal artery recanalization (most frequently mixed) is conduced. Then balloon angioplasty of stenosis or occlusion are carried out. After the angiographic control if necessary stent of all the extension is mounted. The exposure is carried out to the distal part of superficial femoral artery when it lives Hunter's canal and the first portion of popliteal artery. Intermuscular vastoadductoria sept is dissected and the following arteries are ligated and dissected: а. superior medialis genus, а. superior lateralis genus. |
Procedure: Angioplasty with stenting of the femoral artery, supplemented by fasciotomy in Hunter's channel
Standard endovascular stenting of femoral artery. The exposure is carried out to the distal part of superficial femoral artery when it lives Hunter's canal and the first portion of popliteal artery. Intermuscular vastoadductoria sept is dissected and the following arteries are ligated and dissected: а. superior medialis genus, а. superior lateralis genus.
Medical therapy includes aspirin (acid acetylsalicylic) prescription before the procedure (160 - 300 mg/d), beginning from minimum per day and heparin (heparin sodium) injection during the procedure (5000 U iv). After the procedure aspirin (acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and plavix (clopidogrel) in dose 75/d should be prescribed within 3 months.
|
Outcome Measures
Primary Outcome Measures
- Ankle-brachial index [Baseline, 3 days after the operation, 6 month, 12 month, 2 years]
Change in ankle-brachial index.
- Ultrasound scan of the operated segment [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 [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 Outcome Measures
- Number of participants with a successful procedure of revascularization. [During the operation.]
Number of participants with a successful procedure of revascularization.
- Number of participants with complications during the operation. [During the operation.]
Number of participants with complications during the operation.
- Number of participants with limb salvage [3 days after the operation, 6 month, 12 month, 2 years]
Number of participants with limb salvage.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NRICP | Novosibirsk | Russian Federation | 630055 |
Sponsors and Collaborators
- Meshalkin Research Institute of Pathology of Circulation
Investigators
- Study Director: Andrey Karpenko, Scientific-Research Institute of Circulation Pathology named after Academician E. Meshalkin
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- N-RICP-467