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.

NCT02590471 | Unknown Phase 4

• 1 other identifier: N-RICP-467
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis of the Peripheral Artery

Keywords

Angioplasty with stenting of the superficial femoral artery; Fasciotomy in Hunter's channel; Breakage of stent

Outcome Measures

Primary Outcomes (3)

• Ankle-brachial index

  Change in ankle-brachial index.

  Baseline, 3 days after the operation, 6 month, 12 month, 2 years

• 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

• 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

Secondary Outcomes (3)

• Number of participants with a successful procedure of revascularization.

  During the operation.

• Number of participants with complications during the operation.

  During the operation.

• Number of participants with limb salvage

  3 days after the operation, 6 month, 12 month, 2 years

Study Arms (2)

Stenting of the femoral artery.

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.

Procedure: Angioplasty with stenting of the femoral artery

Stenting of the femoral artery and fasciotomy.

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.

Procedure: Angioplasty with stenting of the femoral artery, supplemented by fasciotomy in Hunter's channel

Interventions

Angioplasty with stenting of the femoral artery PROCEDURE

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.

Stenting of the femoral artery.

Angioplasty with stenting of the femoral artery, supplemented by fasciotomy in Hunter's channel PROCEDURE

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.

Stenting of the femoral artery and fasciotomy.

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (1)

NRICP

Novosibirsk, 630055, Russia

Location

Related Publications (1)

• 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.

  PMID: 35366499 DERIVED

MeSH Terms

Interventions

Angioplasty

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Andrey Karpenko

  Scientific-Research Institute of Circulation Pathology named after Academician E. Meshalkin

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: October 29, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: November 1, 2019
• Last Updated: September 27, 2016

Record last verified: 2016-09

Locations

RU (1)