Overview

This trial is active, not recruiting.

Condition atherosclerosis of the peripheral artery
Treatments angioplasty with stenting of the femoral artery, angioplasty with stenting of the femoral artery, supplemented by fasciotomy in hunter's channel
Phase phase 4
Sponsor Meshalkin Research Institute of Pathology of Circulation
Start date October 2015
End date October 2017
Trial size 50 participants
Trial identifier NCT02590471, N-RICP-467

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
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.
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)
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.
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.

Primary Outcomes

Measure
Ankle-brachial index
time frame: Baseline, 3 days after the operation, 6 month, 12 month, 2 years
Ultrasound scan of the operated segment
time frame: Baseline, 3 days after the operation, 6 month, 12 month, 2 years
CT-angiography of lower limb arteries
time frame: Baseline, 3 days after the operation, 6 month, 12 month, 2 years

Secondary Outcomes

Measure
Number of participants with a successful procedure of revascularization.
time frame: During the operation.
Number of participants with complications during the operation.
time frame: During the operation.
Number of participants with limb salvage
time frame: 3 days after the operation, 6 month, 12 month, 2 years

Eligibility Criteria

Male or female participants from 45 years up to 75 years old.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Meshalkin Research Institute of Pathology of Circulation.