AtherosclerosisNCT04590131
Efficacy and Safety Comparison of the Endovascular and the Hybrid Methods for the Treatment of Prolonged Atherosclerotic Lesions of the Femoral-popliteal Segment Above the Knee, TASC II, Type D
A study testing recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent, supplemented by fasciotomy in Hunter's canal. and recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent. in people with Atherosclerosis and Ischemia Limb, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
A recent study, where the authors studied the effectiveness of stenting of prolonged lesions (>200 mm) of the femoral-popliteal segment with nitinol stents (TASC II, D), showed unsatisfactory primary patency rates (45%) within 2 years follow up (Lin et al, 2015). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis, Ischemia Limb, Superficial Femoral Artery Occlusion
- What is being tested?
- recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent, supplemented by fasciotomy in Hunter's canal. and recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 1 Nov 2020to 1 Dec 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age> 18 years;
- CLI category 3 - 6 by Rutherford classification;
- Prolonged atherosclerotic occlusive lesion of the femoropopliteal arterial segment above the knee (Type D by TASC II classification), confirmed by CT or arteriography;
- De novo lesion;
- Patient informed consent.
Who cannot join
- Age < 18;
- Potentially pregnant women;
- Asymptomatic lesion;
- Acute ischemia;
- Previous treatment on the affected segment;
- Not atherosclerotic lesion;
Show all 10Show fewer
- Severe comorbidity with a life expectancy of fewer than 2 years;
- Contraindications to antiplatelet therapy;
- Patient participation in another clinical trial;
- Inability to monitor the patient.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Meshalkin Research Institute of Pathology of Circulation
Novosibirsk, Novosibirsk Area, 630055
Andrey А Karpenko, PHD, MD, +79139504100, andreikarpenko@rambler.ru
Alexander A Gostev, PhD, MD
About this study
Official title: Efficacy and Safety Comparison of the Endovascular (Recanalization With Angioplasty and Stenting With Biomimetic Interwoven Nitinol Stent) and the Hybrid (Recanalization With Angioplasty and Stenting With Biomimetic Interwoven Nitinol Stent, Supplemented With Fasciotomy in Hunter's Canal) Surgical Methods for the Treatment of Prolonged Atherosclerotic Lesions of the Femoral-popliteal Segment Above the Knee, TASC II, Type D
A recent study, where the authors studied the effectiveness of stenting of prolonged lesions (>200 mm) of the femoral-popliteal segment with nitinol stents (TASC II, D), showed unsatisfactory primary patency rates (45%) within 2 years follow up (Lin et al, 2015). One of the possible solutions to the problem of breakage of stents in the femoral-popliteal position is a modified method of their manufacture by braiding from nitinol wire. Another possible solution to the problem of stent breakage in the femoral-popliteal position is fasciotomy in Gunter's canal with dissection of the lamina vasto-adductoria. According to a pilot randomized study (Karpenko et al, 2019), the primary patency at 24 months was 60% in the stenting group supplemented with fasciotomy in Gunter's canal, and 28.5% in the stenting group without fasciotomy. These facts prove the need for a comparative study on a cohort of patients using a biomimetic interwoven nitinol stent. This is a pilot prospective, randomized, open-label study. The main objective of the study is to compare the clinical efficacy and safety of two methods of treating prolonged atherosclerotic lesions (TASC II, type D) of the arteries of the femoropopliteal segment above the knee.
Read the detailed description
A recent study, where the authors studied the effectiveness of stenting of prolonged lesions (>200 mm) of the femoral-popliteal segment with nitinol stents (TASC II, D), showed unsatisfactory primary patency rates (45%) within 2 years follow up (Lin et al, 2015). One of the possible solutions to the problem of breakage of stents in the femoral-popliteal position is a modified method of their manufacture by braiding from nitinol wire. Another possible solution to the problem of stent breakage in the femoral-popliteal position is fasciotomy in Gunter's canal with dissection of the lamina vasto-adductoria. According to a pilot randomized study (Karpenko et al, 2019), the primary patency at 24 months was 60% in the stenting group supplemented with fasciotomy in Gunter's canal, and 28.5% in the stenting group without fasciotomy. These facts prove the need for a comparative study on a cohort of patients using a biomimetic interwoven nitinol stent. This is a pilot prospective, randomized, open-label study. The main objective of the study is to compare the clinical efficacy and safety of two methods of treating prolonged atherosclerotic lesions (TASC II, type D) of the arteries of the femoropopliteal segment above the knee.
Screening It is performed in patients with a verified diagnosed occlusive lesion of the femoropopliteal segment above the knee (type D by TASC II classification), with chronic limb ischemia (3-6 categories by Rutherford classification). Assessment of inclusion / exclusion criteria, assigning a patient number.
Study inclusion Collecting baseline information about the patient (anamnesis, including information about concomitant therapy, data from the initial physical examination, ultrasound data of the lower limb arteries, CT-angiography data, assessment of the quality of life using the SF-36 questionnaire). Randomization using the envelope method to one group or another.
Surgical intervention:
Group 1 (n=50): Recanalization of prolonged occlusion of the arteries of the femoral-popliteal segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent; Group 2 (n=50): Recanalization of prolonged occlusion of the arteries of the femoropopliteal segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent, supplemented by fasciotomy in Gunter's canal.
Follow up: 6, 12, 24 months.
Performed:
Triplex ultrasound of one lower limb (restenosis, thrombosis, stent breakage); Radiography of the operated limb in two projections, for patients in whom a stent breakage is suspected according to ultrasound; Consultation with a cardiovascular surgeon. For each patient participating in the study, a CRF is filled out in a form convenient for the Investigator. The creation of a folder "Investigator's file" is provided, which stores all the necessary documents provided for by the rules of "Good Clinical Practice".
- Conditions
- Atherosclerosis, Ischemia Limb, Superficial Femoral Artery Occlusion, Popliteal Artery Occlusion, Stent Complication
- Being tested
- recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent, supplemented by fasciotomy in Hunter's canal., recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent.
- Keywords
- interwoven nitinol stent, atherosclerosis, prolonged occlusion of SFA, endovascular treatment, hybrid revascularization, TASC II, type D
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent, supplemented by fasciotomy in Hunter's canal.Procedure or surgery
Under local anesthesia, a standard endovascular approach is performed. Transluminal or subintimal recanalization of the occluded arterial segment is performed with a hydrophilic guidewire. Next, balloon angioplasty of the recanalized segment is performed. After control angiography, a biomimetic interwoven nitinol stent is placed throughout the lesion. Immediately after the stenting procedure, under local anesthesia, access to the distal part of the SFA at the outlet of Hunter's canal and 1 portion of the popliteal artery is performed. The lamina vastoadductoria is dissected. The wound is sutured in layers. An aseptic bandage is applied. Drug therapy includes pre-procedure clopidogrel (160-300 mg/day), starting at least one day before, and intra-procedure heparin (100 U / kg body weight intravenously). After the procedure, all patients have prescribed double antiplatelet therapy (aspirin+clopidogrel (75 mg per day) within 6 months and then aspirin 75 mg for a long time.
recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent.Procedure or surgery
Under local anesthesia, a standard endovascular approach is performed and the affected arterial segment is visualized. Transluminal or subintimal recanalization of the occluded arterial segment is performed with a hydrophilic guidewire. Next, balloon angioplasty of the recanalized segment is performed. After control angiography, a biomimetic interwoven nitinol stent is placed throughout the lesion. Drug therapy includes pre-procedure clopidogrel (160-300 mg/day), starting at least one day before, and intra-procedure heparin (100 U / kg body weight intravenously). After the procedure, all patients have prescribed double antiplatelet therapy (aspirin+clopidogrel (75 mg per day) within 6 months and then aspirin 75 mg for a long time.
| Study group | Role | What they receive |
|---|---|---|
| Hubrid revaskularization | Experimental | Patients (n=50) with recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent, supplemented by fasciotomy in Hunter's canal. Receives: Procedure: recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent, supplemented by fasciotomy in Hunter's canal. |
| Endovascular treatment | Active comparator | Patients (n=50) with recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent. Receives: Procedure: recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency
primary patency was defined as absence of occlusion or flow-limiting stenosis (peak systolic velocity [PSV] ratio >2.5) of the treated segment including 1 cm proximal and distal of the anastomosis;
Measured: 24 months
primary assisted patency
primary assisted patency was defined as a secondary procedure is performed to prevent failure (i.e., in a flow-limiting stenosis [PSV ratio >2.5] in a still-patent segment of stent or bypass, including the anastomoses;
Measured: 24 months
secondary patency
secondary patency was defined as a secondary procedure performed for graft or stent occlusion in an afterward patent vessel;
Measured: 24 months
Secondary outcomes (4)
MALE
major adverce limb events
Measured: 24 months
Safety of the methods in the early postoperative period
hematoma of the surgical access area, peripheral neuropathy, purulent-infectious complications of the surgical access area
Measured: 30 days
MACE
major adverce cardio-vascular events
Measured: 24 months
Assessment of the quality of life in patients after surgical treatment
SF-36 questionary
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Nov 2020 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, randomized, open-label, pilot study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590131
- Sponsor's protocol ID
- Sosudi3
- Status last verified
- Oct 2020
- First submitted
- 9 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Comparison of the Endovascular (Recanalization With Angioplasty and Stenting With Biomimetic Interwoven Nitinol Stent) and the Hybrid (Recanalization With Angioplasty and Stenting With Biomimetic Interwoven Nitinol Stent, Supplemented With Fasciotomy in Hunter's Canal) Surgical Methods for the Treatment of Prolonged Atherosclerotic Lesions of the Femoral-popliteal Segment Above the Knee, TASC II, Type D
- ClinicalTrials.gov ID
- NCT04590131
- Acronym / sponsor ID
- Sosudi3
- Conditions
- Atherosclerosis, Ischemia Limb, Superficial Femoral Artery Occlusion, Popliteal Artery Occlusion, Stent Complication
- Keywords
- interwoven nitinol stent, atherosclerosis, prolonged occlusion of SFA, endovascular treatment, hybrid revascularization, TASC II, type D
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 19 Oct 2020 (actual)
- 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.
A recent study, where the authors studied the effectiveness of stenting of prolonged lesions (>200 mm) of the femoral-popliteal segment with nitinol stents (TASC II, D), showed unsatisfactory primary patency rates (45%) within 2 years follow up (Lin et al, 2015). One of the possible solutions to the problem of breakage of stents in the femoral-popliteal position is a modified method of their manufacture by braiding from nitinol wire. Another possible solution to the problem of stent breakage in the femoral-popliteal position is fasciotomy in Gunter's canal with dissection of the lamina vasto-adductoria. According to a pilot randomized study (Karpenko et al, 2019), the primary patency at 24 months was 60% in the stenting group supplemented with fasciotomy in Gunter's canal, and 28.5% in the stenting group without fasciotomy. These facts prove the need for a comparative study on a cohort of patients using a biomimetic interwoven nitinol stent. This is a pilot prospective, randomized, open-label study. The main objective of the study is to compare the clinical efficacy and safety of two methods of treating prolonged atherosclerotic lesions (TASC II, type D) of the arteries of the femoropopliteal segment above the knee.
Detailed description
A recent study, where the authors studied the effectiveness of stenting of prolonged lesions (>200 mm) of the femoral-popliteal segment with nitinol stents (TASC II, D), showed unsatisfactory primary patency rates (45%) within 2 years follow up (Lin et al, 2015). One of the possible solutions to the problem of breakage of stents in the femoral-popliteal position is a modified method of their manufacture by braiding from nitinol wire. Another possible solution to the problem of stent breakage in the femoral-popliteal position is fasciotomy in Gunter's canal with dissection of the lamina vasto-adductoria. According to a pilot randomized study (Karpenko et al, 2019), the primary patency at 24 months was 60% in the stenting group supplemented with fasciotomy in Gunter's canal, and 28.5% in the stenting group without fasciotomy. These facts prove the need for a comparative study on a cohort of patients using a biomimetic interwoven nitinol stent. This is a pilot prospective, randomized, open-label study. The main objective of the study is to compare the clinical efficacy and safety of two methods of treating prolonged atherosclerotic lesions (TASC II, type D) of the arteries of the femoropopliteal segment above the knee.
Screening It is performed in patients with a verified diagnosed occlusive lesion of the femoropopliteal segment above the knee (type D by TASC II classification), with chronic limb ischemia (3-6 categories by Rutherford classification). Assessment of inclusion / exclusion criteria, assigning a patient number.
Study inclusion Collecting baseline information about the patient (anamnesis, including information about concomitant therapy, data from the initial physical examination, ultrasound data of the lower limb arteries, CT-angiography data, assessment of the quality of life using the SF-36 questionnaire). Randomization using the envelope method to one group or another.
Surgical intervention:
Group 1 (n=50): Recanalization of prolonged occlusion of the arteries of the femoral-popliteal segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent; Group 2 (n=50): Recanalization of prolonged occlusion of the arteries of the femoropopliteal segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent, supplemented by fasciotomy in Gunter's canal.
Follow up: 6, 12, 24 months.
Performed:
Triplex ultrasound of one lower limb (restenosis, thrombosis, stent breakage); Radiography of the operated limb in two projections, for patients in whom a stent breakage is suspected according to ultrasound; Consultation with a cardiovascular surgeon. For each patient participating in the study, a CRF is filled out in a form convenient for the Investigator. The creation of a folder "Investigator's file" is provided, which stores all the necessary documents provided for by the rules of "Good Clinical Practice".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, randomized, open-label, pilot study
| Arm | Type | Receives |
|---|---|---|
| Hubrid revaskularization | Experimental | Procedure: recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent, supplemented by fasciotomy in Hunter's canal.Patients (n=50) with recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent, supplemented by fasciotomy in Hunter's canal. |
| Endovascular treatment | Active comparator | Procedure: recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent.Patients (n=50) with recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age> 18 years;
- CLI category 3 - 6 by Rutherford classification;
- Prolonged atherosclerotic occlusive lesion of the femoropopliteal arterial segment above the knee (Type D by TASC II classification), confirmed by CT or arteriography;
- De novo lesion;
- Patient informed consent.
Key exclusion criteria (10 listed)
- Age < 18;
- Potentially pregnant women;
- Asymptomatic lesion;
- Acute ischemia;
- Previous treatment on the affected segment;
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 |
|---|---|---|
| recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent, supplemented by fasciotomy in Hunter's canal.Under local anesthesia, a standard endovascular approach is performed. Transluminal or subintimal recanalization of the occluded arterial segment is performed with a hydrophilic guidewire. Next, balloon angioplasty of the recanalized segment is performed. After control angiography, a biomimetic interwoven nitinol stent is placed throughout the lesion. Immediately after the stenting procedure, under local anesthesia, access to the distal part of the SFA at the outlet of Hunter's canal and 1 portion of the popliteal artery is performed. The lamina vastoadductoria is dissected. The wound is sutured in layers. An aseptic bandage is applied. Drug therapy includes pre-procedure clopidogrel (160-300 mg/day), starting at least one day before, and intra-procedure heparin (100 U / kg body weight intravenously). After the procedure, all patients have prescribed double antiplatelet therapy (aspirin+clopidogrel (75 mg per day) within 6 months and then aspirin 75 mg for a long time. | Procedure or surgery | Hubrid revaskularization |
| recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent.Under local anesthesia, a standard endovascular approach is performed and the affected arterial segment is visualized. Transluminal or subintimal recanalization of the occluded arterial segment is performed with a hydrophilic guidewire. Next, balloon angioplasty of the recanalized segment is performed. After control angiography, a biomimetic interwoven nitinol stent is placed throughout the lesion. Drug therapy includes pre-procedure clopidogrel (160-300 mg/day), starting at least one day before, and intra-procedure heparin (100 U / kg body weight intravenously). After the procedure, all patients have prescribed double antiplatelet therapy (aspirin+clopidogrel (75 mg per day) within 6 months and then aspirin 75 mg for a long time. | Procedure or surgery | Endovascular treatment |
Primary outcome
Primary patency
Time frame: 24 months
primary patency was defined as absence of occlusion or flow-limiting stenosis (peak systolic velocity [PSV] ratio >2.5) of the treated segment including 1 cm proximal and distal of the anastomosis;
primary assisted patency
Time frame: 24 months
primary assisted patency was defined as a secondary procedure is performed to prevent failure (i.e., in a flow-limiting stenosis [PSV ratio >2.5] in a still-patent segment of stent or bypass, including the anastomoses;
secondary patency
Time frame: 24 months
secondary patency was defined as a secondary procedure performed for graft or stent occlusion in an afterward patent vessel;
4 secondary outcomes
MALE
Time frame: 24 months
Safety of the methods in the early postoperative period
Time frame: 30 days
MACE
Time frame: 24 months
Assessment of the quality of life in patients after surgical treatment
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent, supplemented by fasciotomy in Hunter's canal. and recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent. in people with Atherosclerosis and Ischemia Limb, 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 5 inclusion and 10 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 19 Oct 2020. 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.
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?
Contact Andrey A Karpenko, PHD, MD (+79139504100, andreikarpenko@rambler.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency (time frame: 24 months). 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?
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 19 Oct 2020; AzTrials last refreshed its copy on 8 Nov 2026.