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.

Atherosclerosis of the Peripheral Artery Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02590471
• Other study ID #: N-RICP-467
• Status: Active, not recruiting
• Phase: Phase 4
• First received: October 23, 2015
• Last updated: September 25, 2016
• Start date: October 2015
• Est. completion date: November 2019

Study information

• Verified date: September 2016
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: November 2019
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerosis of the Peripheral Artery

Intervention

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.
• 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: ?. superior medialis genus, ?. 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.

Locations

Country	Name	City	State
Russian Federation	NRICP	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ankle-brachial index	Change in ankle-brachial index.	Baseline, 3 days after the operation, 6 month, 12 month, 2 years	No
Primary	Ultrasound scan of the operated segment	The degree of stenosis in the operated segment.	Baseline, 3 days after the operation, 6 month, 12 month, 2 years	No
Primary	CT-angiography of lower limb arteries	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.	Baseline, 3 days after the operation, 6 month, 12 month, 2 years	No
Secondary	Number of participants with a successful procedure of revascularization.	Number of participants with a successful procedure of revascularization.	During the operation.	No
Secondary	Number of participants with complications during the operation.	Number of participants with complications during the operation.	During the operation.	No
Secondary	Number of participants with limb salvage	Number of participants with limb salvage.	3 days after the operation, 6 month, 12 month, 2 years	No