Clinical trial NCT02590471: 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.
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atherosclerosis of the Peripheral Artery
Keywords: Angioplasty with stenting of the superficial femoral artery
Fasciotomy in Hunter's channel
Breakage of stent
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2015-10-29
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Ankle-brachial index
timeFrame: Baseline, 3 days after the operation, 6 month, 12 month, 2 years
measure: Ultrasound scan of the operated segment
timeFrame: Baseline, 3 days after the operation, 6 month, 12 month, 2 years
measure: CT-angiography of lower limb arteries
timeFrame: Baseline, 3 days after the operation, 6 month, 12 month, 2 years
Secondary outcomes:
measure: Number of participants with a successful procedure of revascularization.
timeFrame: During the operation.
measure: Number of participants with complications during the operation.
timeFrame: During the operation.
measure: Number of participants with limb salvage
timeFrame: 3 days after the operation, 6 month, 12 month, 2 years
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: NRICP
Study officials:
affiliation: Scientific-Research Institute of Circulation Pathology named after Academician E. Meshalkin
name: Andrey Karpenko
role: STUDY_DIRECTOR
References:
citation: Karpenko AA, Rabtsun AA, Popova IV, Saaya SB, Gostev AA, Ignatenko PV, Starodubtsev VB, Cheban AV. Influence of lamina vastoadductoria dissection on the outcomes of femoral artery extensive lesion stenting: A pilot randomised investigation. J Biomech. 2022 May;136:111053. doi: 10.1016/j.jbiomech.2022.111053. Epub 2022 Mar 19.