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.

Phase 4

• Conditions: Atherosclerosis of the Peripheral Artery
• Interventions: Procedure: Angioplasty with stenting of the femoral artery; Procedure: Angioplasty with stenting of the femoral artery, supplemented by fasciotomy in Hunter's channel

• Registration Number: NCT02590471
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-23
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-29
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-25
• Last Update Posted: 2016-09-27
• Primary Completion: 2017-10
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stenting of the femoral artery.	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 of all the extension is mounted.
Stenting of the femoral artery and fasciotomy.	Angioplasty with stenting of the femoral artery, supplemented by fasciotomy in Hunter's channel	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

NRICP; 🇷🇺 Novosibirsk, Russian Federation