Back to resultsPilot 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.
Primary Purpose
Atherosclerosis of the Peripheral Artery
Status
Unknown status
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Angioplasty with stenting of the femoral artery
Angioplasty with stenting of the femoral artery, supplemented by fasciotomy in Hunter's channel
Sponsored by
About this trial
This is an interventional treatment trial for Atherosclerosis of the Peripheral Artery focused on measuring Angioplasty with stenting of the superficial femoral artery, Fasciotomy in Hunter's channel, Breakage of stent
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
Sites / Locations
- NRICP
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Stenting of the femoral artery.
Stenting of the femoral artery and fasciotomy.
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Ankle-brachial index
Change in ankle-brachial index.
Ultrasound scan of the operated segment
The degree of stenosis in the operated segment.
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.
Secondary Outcome Measures
Number of participants with a successful procedure of revascularization.
Number of participants with a successful procedure of revascularization.
Number of participants with complications during the operation.
Number of participants with complications during the operation.
Number of participants with limb salvage
Number of participants with limb salvage.
Full Information
NCT ID
NCT02590471
First Posted
October 23, 2015
Last Updated
September 25, 2016
Sponsor
Meshalkin Research Institute of Pathology of Circulation
1. Study Identification
Unique Protocol Identification Number
NCT02590471
Brief Title
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
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
November 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis of the Peripheral Artery
Keywords
Angioplasty with stenting of the superficial femoral artery, Fasciotomy in Hunter's channel, Breakage of stent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stenting of the femoral artery.
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Stenting of the femoral artery and fasciotomy.
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Angioplasty with stenting of the femoral artery
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Angioplasty with stenting of the femoral artery, supplemented by fasciotomy in Hunter's channel
Intervention Description
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 Outcome Measure Information:
Title
Ankle-brachial index
Description
Change in ankle-brachial index.
Time Frame
Baseline, 3 days after the operation, 6 month, 12 month, 2 years
Title
Ultrasound scan of the operated segment
Description
The degree of stenosis in the operated segment.
Time Frame
Baseline, 3 days after the operation, 6 month, 12 month, 2 years
Title
CT-angiography of lower limb arteries
Description
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.
Time Frame
Baseline, 3 days after the operation, 6 month, 12 month, 2 years
Secondary Outcome Measure Information:
Title
Number of participants with a successful procedure of revascularization.
Description
Number of participants with a successful procedure of revascularization.
Time Frame
During the operation.
Title
Number of participants with complications during the operation.
Description
Number of participants with complications during the operation.
Time Frame
During the operation.
Title
Number of participants with limb salvage
Description
Number of participants with limb salvage.
Time Frame
3 days after the operation, 6 month, 12 month, 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrey Karpenko
Organizational Affiliation
Scientific-Research Institute of Circulation Pathology named after Academician E. Meshalkin
Official's Role
Study Director
Facility Information:
Facility Name
NRICP
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
12. IPD Sharing Statement
Citations:
PubMed Identifier
35366499
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.
Results Reference
derived
Learn more about this trial
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.
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