AtherosclerosisNCT04588571
Efficacy and Safety Comparison of the Open Surgical and Endovascular Methods for the Treatment of Long Atherosclerotic Lesions of the Femoral-popliteal Segment Above the Knee, TASC II, Type D.
A study testing Endovascular recanalization with angioplasty and stenting with the biomimetic interwoven nitinol stent and Femoropopliteal proximal bypass in people with Atherosclerosis and Ischemia Limb, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
Endovascular revascularization and open bypass grafting above the knee show comparable results in primary 2-year patency (about 65%) in medium-length lesions - TASC II, C (Pereira et al, 2006). 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?
- Endovascular recanalization with angioplasty and stenting with the biomimetic interwoven nitinol stent and Femoropopliteal proximal bypass
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteRussia
- Study dates
- 1 Oct 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;
- Symptomatic lesion (Rutherford category 3 - 6);
- Atherosclerotic prolonged occlusive lesion of the femoropopliteal arterial segment above the knee, classified by TASC II as type D, confirmed by computed tomography or arteriography;
- De novo lesion;
- Patient informed consent.
Who cannot join
- Age < 18 years old;
- Potentially pregnant women;
- Asymptomatic lesion;
- Acute ischemia;
- Not de novo lesion;
- Severe comorbidity with a life expectancy of fewer than 2 years;
- Contraindications to antiplatelet therapy (double antiplatelet therapy is required for at least 2 months after the intervention);
- Patient participation in another clinical trial;
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 Open (Femoral-popliteal Proximal Bypass) and Endovascular (Recanalization With Angioplasty and Stenting With Biomimetic Interwoven Nitinol Stent) Surgical Methods for the Treatment of Long Atherosclerotic Lesions of the Femoral-popliteal Segment Above the Knee, TASC II, Type D
Endovascular revascularization and open bypass grafting above the knee show comparable results in primary 2-year patency (about 65%) in medium-length lesions - TASC II, C (Pereira et al, 2006). At the same time, a recent study, where the authors studied the effectiveness of stenting of long lesions (200 mm or more) of the chronic occlusions of the femoropopliteal segments (TASC II, D), showed unsatisfactory results (primary patency 45%) of the stented segment within 2 years (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. Some studies with intervowen nitinol stents did show their resistance to breakage in this position. Moreover, the primary patency was > 70%. (Werner et al, 2014). These data suggest a better primary patency rate within 2 years with a longer lesion length (>200 mm).
This is a prospective, randomized, open-label study. The main objective of the study is to compare the clinical efficacy and safety of two therapies for the treatment of prolonged atherosclerotic lesions of the arteries of the femoropopliteal segment above the knee, TASC II type D - femoropopliteal proximal shunting and recanalization with angioplasty and stenting using biomimetic interwoven nitinol stent in patients with symptomatic peripheral arterial disease at 24 months. Secondary objectives are to identify predictors of restenosis and occlusions of the operating segment and compare the quality of life of patients after the procedure. It is planned to recruit 110 patients (55 patients in each group). Observation period 2 years. Primary endpoint:
Read more
-The effectiveness of the method of surgical treatment after 24 months (primary patency, primary-assisted patency, secondary patency).
Secondary endpoints:
- Clinical efficacy of the method of surgical treatment after 24 months (MALE);
- Safety of the method of surgical treatment in the early postoperative period (hematoma of the surgical access area, peripheral neuropathy, purulent-infectious complications of the surgical access area) and after 24 months (MACE);
- Assessment of the quality of life in patients after surgical treatment at 6, 12, and 24 months (SF-36 questionnaire);
- Evaluation of prognostic factors for adverse outcomes after surgical treatment.
Read the detailed description
Endovascular revascularization and open bypass grafting above the knee show comparable results in primary 2-year patency (about 65%) in medium-length lesions - TASC II, C (Pereira et al, 2006). At the same time, a recent study, where the authors studied the effectiveness of stenting of long lesions (200 mm or more) of the chronic occlusions of the femoropopliteal segments (TASC II, D), showed unsatisfactory results (primary patency 45%) of the stented segment within 2 years (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. Some studies with interwoven nitinol stents did show their resistance to breakage in this position. Moreover, the primary patency was > 70%. (Werner et al, 2014). These data suggest a better primary patency rate within 2 years with a longer lesion length (>200 mm).
This is a prospective, randomized, open-label study. The main objective of the study is to compare the clinical efficacy and safety of two therapies for the treatment of prolonged atherosclerotic lesions of the arteries of the femoropopliteal segment above the knee, TASC II type D - femoropopliteal proximal shunting and recanalization with angioplasty and stenting using biomimetic interwoven nitinol stent in patients with symptomatic peripheral arterial disease at 24 months. Secondary objectives are to identify predictors of restenosis and occlusions of the operating segment and compare the quality of life of patients after the procedure.
The analysis of literature data showed, that two-year primary patency after endovascular revascularization using a nitinol stent in long lesions was 60%. At the same time, the two-year primary patency after the femoropopliteal proximal bypass was 56% (Enzmann et al. Nitinol stent versus bypass in long femoropopliteal lesions: 2-year results of a randomized controlled trial. JACC: Cardiovascular Interventions. 2019 Dec 23; 12 (24): 2541-9.). Considering these data, it should be assumed that the use of biomimetic interwoven nitinol stents will slightly improve the primary patency parameters within 2 years in the stenting group. The 2-year primary patency after stenting of the femoropopliteal segment with an interwoven nitinol stent was 76% (Scheinert et al., 2011). A power analysis was performed to calculate the sample size of the "non-inferiority" design for a study power of 80%, a type 1 error probability of 5%, and a non-inferiority margin of 10%. It is planned to recruit 110 patients (55 patients in each group). The observation period of 2 years. Primary endpoint:
-The effectiveness of the method of surgical treatment after 24 months (primary patency, primary-assisted patency, secondary patency).
Secondary endpoints:
- Clinical efficacy of the method of surgical treatment after 24 months (MALE);
- Safety of the method of surgical treatment in the early postoperative period (hematoma of the surgical access area, peripheral neuropathy, purulent-infectious complications of the surgical access area) and after 24 months (MACE);
- Assessment of the quality of life in patients after surgical treatment at 6, 12, and 24 months (SF-36 questionnaire);
- Evaluation of prognostic factors for adverse outcomes after surgical treatment. Screening It is performed in patients with a verified diagnosed occlusive lesion of the femoropopliteal segment above the knee joint (type D according to the TASC II classification), with chronic ischemia of the lower extremities of 3-6 categories according to Rutherford.
- Assessment of inclusion/exclusion criteria
- Assigning a patient number
Study inclusion Collecting baseline information about the patient (history, including information about concomitant therapy, data from the initial physical examination, ultrasound data of the lower limb arteries, CT -arteriography data, assessment of the quality of life using the SF-36 questionnaire. Randomization using the envelope method to one group or another.
Group 1: Femoropopliteal proximal bypass; Group 2: Recanalization of prolonged occlusion of the arteries of the femoral-popliteal segment above the knee joint with angioplasty and stenting with a biomimetic interwoven nitinol stent.
Follow up period; 6, 12, and 24 months.
Performed:
Triplex ultrasound of one lower limb (restenosis, thrombosis, stent breakage);
- Leg's roentgenography for the stenting group in two projections, for patients in whom a stent breakage is suspected according to ultrasound;
- Consultation with a cardiovascular surgeon.
- Conditions
- Atherosclerosis, Ischemia Limb, Superficial Femoral Artery Occlusion, Popliteal Artery Occlusion
- Being tested
- Endovascular recanalization with angioplasty and stenting with the biomimetic interwoven nitinol stent, Femoropopliteal proximal bypass
- Keywords
- interwoven nitinol stent, atherosclerosis, prolonged occlusion of SFA, endovascular treatment, femoro-popliteal bypass, 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.
Endovascular recanalization with angioplasty and stenting with the biomimetic interwoven nitinol stentProcedure 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 aspirin (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 aspirin (100 mg per day) for a long time and clopidogrel (75 mg per day) for 3 months.
Femoropopliteal proximal bypassProcedure or surgery
Under general anesthesia, 2 standard open surgical approaches are performed: first - to the common femoral artery, superficial femoral artery, and deep femoral artery; the second - to the first portion of the popliteal artery. After systemic heparinization, clamps are applied to the arteries. A longitudinal arteriotomy of the popliteal artery is performed, and a distal end-to-side anastomosis is formed between the artery and the shunt. Next, the shunt is passed into the groin wound. Longitudinal arteriotomy of the common femoral artery. A proximal end-to-side anastomosis is formed between the shunt and the common femoral artery. Surgical hemostasis wound drainage and layer-by-layer wound closure are performed.
Drug therapy includes pre-procedure aspirin (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 aspirin (75-100 mg per day) for a long time.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular treatment | Experimental | Patients (n=55) with recanalization of the femoral-popliteal arterial segment (TASC II, type D) above the knee with a biomimetic braided nitinol stent. Receives: Procedure: Endovascular recanalization with angioplasty and stenting with the biomimetic interwoven nitinol stent |
| Open surgery | Active comparator | Patients (n=55) with femoropopliteal proximal bypass with a prolonged atherosclerotic lesion of the femoropopliteal arterial segment (TASC II, type D). Receives: Procedure: Femoropopliteal proximal bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary patency
primary patency is 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 is defined as a secondary procedure is performed to prevent failure (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 is 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 surgical treatment 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 cardiovascular events, deaths
Measured: 24 months
Assessment of the quality of life
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 Oct 2020
- Primary completion1 Oct 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
- This is a prospective, randomized, open-label study. Group 1 (n=55): Femoropopliteal proximal bypass. Group 2 (n=55): Recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent.
- Masking
- None (open label)
- Enrolment
- 110 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
- NCT04588571
- Sponsor's protocol ID
- Sosudi2
- Status last verified
- Oct 2020
- First submitted
- 8 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 Open (Femoral-popliteal Proximal Bypass) and Endovascular (Recanalization With Angioplasty and Stenting With Biomimetic Interwoven Nitinol Stent) Surgical Methods for the Treatment of Long Atherosclerotic Lesions of the Femoral-popliteal Segment Above the Knee, TASC II, Type D
- ClinicalTrials.gov ID
- NCT04588571
- Acronym / sponsor ID
- Sosudi2
- Conditions
- Atherosclerosis, Ischemia Limb, Superficial Femoral Artery Occlusion, Popliteal Artery Occlusion
- Keywords
- interwoven nitinol stent, atherosclerosis, prolonged occlusion of SFA, endovascular treatment, femoro-popliteal bypass, TASC II, type D
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Oct 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.
Endovascular revascularization and open bypass grafting above the knee show comparable results in primary 2-year patency (about 65%) in medium-length lesions - TASC II, C (Pereira et al, 2006). At the same time, a recent study, where the authors studied the effectiveness of stenting of long lesions (200 mm or more) of the chronic occlusions of the femoropopliteal segments (TASC II, D), showed unsatisfactory results (primary patency 45%) of the stented segment within 2 years (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. Some studies with intervowen nitinol stents did show their resistance to breakage in this position. Moreover, the primary patency was > 70%. (Werner et al, 2014). These data suggest a better primary patency rate within 2 years with a longer lesion length (>200 mm).
This is a prospective, randomized, open-label study. The main objective of the study is to compare the clinical efficacy and safety of two therapies for the treatment of prolonged atherosclerotic lesions of the arteries of the femoropopliteal segment above the knee, TASC II type D - femoropopliteal proximal shunting and recanalization with angioplasty and stenting using biomimetic interwoven nitinol stent in patients with symptomatic peripheral arterial disease at 24 months. Secondary objectives are to identify predictors of restenosis and occlusions of the operating segment and compare the quality of life of patients after the procedure. It is planned to recruit 110 patients (55 patients in each group). Observation period 2 years. Primary endpoint:
-The effectiveness of the method of surgical treatment after 24 months (primary patency, primary-assisted patency, secondary patency).
Secondary endpoints:
- Clinical efficacy of the method of surgical treatment after 24 months (MALE);
- Safety of the method of surgical treatment in the early postoperative period (hematoma of the surgical access area, peripheral neuropathy, purulent-infectious complications of the surgical access area) and after 24 months (MACE);
- Assessment of the quality of life in patients after surgical treatment at 6, 12, and 24 months (SF-36 questionnaire);
- Evaluation of prognostic factors for adverse outcomes after surgical treatment.
Detailed description
Endovascular revascularization and open bypass grafting above the knee show comparable results in primary 2-year patency (about 65%) in medium-length lesions - TASC II, C (Pereira et al, 2006). At the same time, a recent study, where the authors studied the effectiveness of stenting of long lesions (200 mm or more) of the chronic occlusions of the femoropopliteal segments (TASC II, D), showed unsatisfactory results (primary patency 45%) of the stented segment within 2 years (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. Some studies with interwoven nitinol stents did show their resistance to breakage in this position. Moreover, the primary patency was > 70%. (Werner et al, 2014). These data suggest a better primary patency rate within 2 years with a longer lesion length (>200 mm).
This is a prospective, randomized, open-label study. The main objective of the study is to compare the clinical efficacy and safety of two therapies for the treatment of prolonged atherosclerotic lesions of the arteries of the femoropopliteal segment above the knee, TASC II type D - femoropopliteal proximal shunting and recanalization with angioplasty and stenting using biomimetic interwoven nitinol stent in patients with symptomatic peripheral arterial disease at 24 months. Secondary objectives are to identify predictors of restenosis and occlusions of the operating segment and compare the quality of life of patients after the procedure.
The analysis of literature data showed, that two-year primary patency after endovascular revascularization using a nitinol stent in long lesions was 60%. At the same time, the two-year primary patency after the femoropopliteal proximal bypass was 56% (Enzmann et al. Nitinol stent versus bypass in long femoropopliteal lesions: 2-year results of a randomized controlled trial. JACC: Cardiovascular Interventions. 2019 Dec 23; 12 (24): 2541-9.). Considering these data, it should be assumed that the use of biomimetic interwoven nitinol stents will slightly improve the primary patency parameters within 2 years in the stenting group. The 2-year primary patency after stenting of the femoropopliteal segment with an interwoven nitinol stent was 76% (Scheinert et al., 2011). A power analysis was performed to calculate the sample size of the "non-inferiority" design for a study power of 80%, a type 1 error probability of 5%, and a non-inferiority margin of 10%. It is planned to recruit 110 patients (55 patients in each group). The observation period of 2 years. Primary endpoint:
-The effectiveness of the method of surgical treatment after 24 months (primary patency, primary-assisted patency, secondary patency).
Secondary endpoints:
- Clinical efficacy of the method of surgical treatment after 24 months (MALE);
- Safety of the method of surgical treatment in the early postoperative period (hematoma of the surgical access area, peripheral neuropathy, purulent-infectious complications of the surgical access area) and after 24 months (MACE);
- Assessment of the quality of life in patients after surgical treatment at 6, 12, and 24 months (SF-36 questionnaire);
- Evaluation of prognostic factors for adverse outcomes after surgical treatment. Screening It is performed in patients with a verified diagnosed occlusive lesion of the femoropopliteal segment above the knee joint (type D according to the TASC II classification), with chronic ischemia of the lower extremities of 3-6 categories according to Rutherford.
- Assessment of inclusion/exclusion criteria
- Assigning a patient number
Study inclusion Collecting baseline information about the patient (history, including information about concomitant therapy, data from the initial physical examination, ultrasound data of the lower limb arteries, CT -arteriography data, assessment of the quality of life using the SF-36 questionnaire. Randomization using the envelope method to one group or another.
Group 1: Femoropopliteal proximal bypass; Group 2: Recanalization of prolonged occlusion of the arteries of the femoral-popliteal segment above the knee joint with angioplasty and stenting with a biomimetic interwoven nitinol stent.
Follow up period; 6, 12, and 24 months.
Performed:
Triplex ultrasound of one lower limb (restenosis, thrombosis, stent breakage);
- Leg's roentgenography for the stenting group in two projections, for patients in whom a stent breakage is suspected according to ultrasound;
- Consultation with a cardiovascular surgeon.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, open-label study. Group 1 (n=55): Femoropopliteal proximal bypass. Group 2 (n=55): Recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent.
| Arm | Type | Receives |
|---|---|---|
| Endovascular treatment | Experimental | Procedure: Endovascular recanalization with angioplasty and stenting with the biomimetic interwoven nitinol stentPatients (n=55) with recanalization of the femoral-popliteal arterial segment (TASC II, type D) above the knee with a biomimetic braided nitinol stent. |
| Open surgery | Active comparator | Procedure: Femoropopliteal proximal bypassPatients (n=55) with femoropopliteal proximal bypass with a prolonged atherosclerotic lesion of the femoropopliteal arterial segment (TASC II, type D). |
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;
- Symptomatic lesion (Rutherford category 3 - 6);
- Atherosclerotic prolonged occlusive lesion of the femoropopliteal arterial segment above the knee, classified by TASC II as type D, confirmed by computed tomography or arteriography;
- De novo lesion;
- Patient informed consent.
Key exclusion criteria (8 listed)
- Age < 18 years old;
- Potentially pregnant women;
- Asymptomatic lesion;
- Acute ischemia;
- Not de novo lesion;
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 |
|---|---|---|
| Endovascular recanalization with angioplasty and stenting with the biomimetic interwoven nitinol stentUnder 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 aspirin (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 aspirin (100 mg per day) for a long time and clopidogrel (75 mg per day) for 3 months. | Procedure or surgery | Endovascular treatment |
| Femoropopliteal proximal bypassUnder general anesthesia, 2 standard open surgical approaches are performed: first - to the common femoral artery, superficial femoral artery, and deep femoral artery; the second - to the first portion of the popliteal artery. After systemic heparinization, clamps are applied to the arteries. A longitudinal arteriotomy of the popliteal artery is performed, and a distal end-to-side anastomosis is formed between the artery and the shunt. Next, the shunt is passed into the groin wound. Longitudinal arteriotomy of the common femoral artery. A proximal end-to-side anastomosis is formed between the shunt and the common femoral artery. Surgical hemostasis wound drainage and layer-by-layer wound closure are performed. Drug therapy includes pre-procedure aspirin (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 aspirin (75-100 mg per day) for a long time. | Procedure or surgery | Open surgery |
Primary outcome
primary patency
Time frame: 24 months
primary patency is 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 is defined as a secondary procedure is performed to prevent failure (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 is 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 surgical treatment in the early postoperative period
Time frame: 30 days
MACE
Time frame: 24 months
Assessment of the quality of life
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.
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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 Endovascular recanalization with angioplasty and stenting with the biomimetic interwoven nitinol stent and Femoropopliteal proximal bypass 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 8 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.