Atherosclerosis of the Peripheral ArteryPhase 4NCT02590471
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.
A Phase 4 study testing Angioplasty with stenting of the femoral artery and Angioplasty with stenting of the femoral artery, supplemented by fasciotomy in Hunter's channel in people with Atherosclerosis of the Peripheral Artery, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Atherosclerosis of the Peripheral Artery
- What is being tested?
- Angioplasty with stenting of the femoral artery and Angioplasty with stenting of the femoral artery, supplemented by fasciotomy in Hunter's channel
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- Oct 2015to Nov 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Expressed aortic calcification tolerant to angioplasty
- Patients with significant common femoral artery lesion
- Patient refusal to participate or continue to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Atherosclerosis of the Peripheral Artery
- Being tested
- Angioplasty with stenting of the femoral artery, Angioplasty with stenting of the femoral artery, supplemented by fasciotomy in Hunter's channel
- Keywords
- Angioplasty with stenting of the superficial femoral artery, Fasciotomy in Hunter's channel, Breakage of stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angioplasty with stenting of the femoral arteryProcedure or surgery
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 channelProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Angioplasty with stenting of the femoral artery, supplemented by fasciotomy in Hunter's channel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle-brachial index
Change in ankle-brachial index.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 days after the operation, 6 month, 12 month, 2 years
Secondary outcomes (3)
Number of participants with a successful procedure of revascularization.
Number of participants with a successful procedure of revascularization.
Measured: During the operation.
Number of participants with complications during the operation.
Number of participants with complications during the operation.
Measured: During the operation.
Number of participants with limb salvage
Number of participants with limb salvage.
Measured: 3 days after the operation, 6 month, 12 month, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2017 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atherosclerosis of the Peripheral ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Andrey Karpenko, Study director, Scientific-Research Institute of Circulation Pathology named after Academician E. Meshalkin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590471
- Sponsor's protocol ID
- N-RICP-467
- Status last verified
- Sep 2016
- First submitted
- 23 Oct 2015
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35366499
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02590471
- Acronym / sponsor ID
- N-RICP-467
- Conditions
- Atherosclerosis of the Peripheral Artery
- Keywords
- Angioplasty with stenting of the superficial femoral artery, Fasciotomy in Hunter's channel, Breakage of stent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Oct 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stenting of the femoral artery. | Active comparator | Procedure: Angioplasty with stenting of the femoral arteryA 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. |
| Stenting of the femoral artery and fasciotomy. | Experimental | Procedure: Angioplasty with stenting of the femoral artery, supplemented by fasciotomy in Hunter's channelUnder 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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angioplasty with stenting of the femoral arteryA 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. | Procedure or surgery | Stenting of the femoral artery. |
| Angioplasty with stenting of the femoral artery, supplemented by fasciotomy in Hunter's channelStandard 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. | Procedure or surgery | Stenting of the femoral artery and fasciotomy. |
Primary outcome
Ankle-brachial index
Time frame: Baseline, 3 days after the operation, 6 month, 12 month, 2 years
Change in ankle-brachial index.
Ultrasound scan of the operated segment
Time frame: Baseline, 3 days after the operation, 6 month, 12 month, 2 years
The degree of stenosis in the operated segment.
CT-angiography of lower limb arteries
Time frame: Baseline, 3 days after the operation, 6 month, 12 month, 2 years
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.
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- Derived from this study: PubMed 35366499Karpenko 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.
Related trials for Atherosclerosis of the Peripheral Artery
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Active, not recruiting
Thromboelastography With Platelet Mapping to Guide Antiplatelet Therapy After Lower Extremity Revascularization
Thrombosis, Arterial Occlusive Diseases
Active, not recruiting
SELUTION4SFA Trial
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
RecruitingPhase 3
Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease
Peripheral Arterial Disease
Not yet recruitingObservational study
Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
Femoropopliteal In-Stent Restenosis (ISR)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrey Karpenko study director
Scientific-Research Institute of Circulation Pathology named after Academician E. Meshalkin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Angioplasty with stenting of the femoral artery and Angioplasty with stenting of the femoral artery, supplemented by fasciotomy in Hunter's channel in people with Atherosclerosis of the Peripheral Artery, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle-brachial index (time frame: Baseline, 3 days after the operation, 6 month, 12 month, 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02590471, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2016.