Steno-occlusive Desease of Femoro-popliteal Arterial SegmentNCT02948166
Remote Endarterectomy and Endovascular Treatments in Patients With the Femoral Artery Occlusive Disease
A study testing Angioplasty with stenting of the femoral artery and Open surgery in people with Steno-occlusive Desease of Femoro-popliteal Arterial Segment, 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: remote endarterectomy vs. stenting of the superficial femoral artery cin 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
- Steno-occlusive Desease of Femoro-popliteal Arterial Segment
- What is being tested?
- Angioplasty with stenting of the femoral artery and Open surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteRussia
- Study dates
- Jan 2016to Jan 2019
- 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 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 femoral artery 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
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- 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.
Russia1 site, 1 recruiting
- Recruiting
Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology
Novosibirsk, 630055
Artem Rabtsun, +79137078354, a_rabtsun@meshalkin.ru
About this study
Official title: Prospective Randomized Clinical Trial of the Remote Endarterectomy and the Femoral Arteries Endovascular Treatments in Patients With the Femoral Artery Occlusive Disease (TASC C, D)
Comparison of two methods for revascularization of the superficial femoral artery: remote endarterectomy vs. stenting of the superficial femoral artery cin patients with steno-occlusive lesion of the femoro-popliteal segment of TASC C, D
Read the detailed description
Reported local percutaneous angioplasty and stenosis of femoral popliteal arteries indicate that the primary technical and clinical success above 95%. The technical success of recanalization of long occlusions femoral arteries less than 80%. Improvement of endovascular equipment designed for the treatment of total occlusions, increases the technical success of recanalization. The materials of the TASC II summarizes the results of several large studies that presented data on the operated segment artery patency at 56-73,7% within 2 years of observation. An alternative method of revascularization own femoral artery is remote endarterectomy. The two-year primary patency at remote endarterectomy is 86% (Moll F.L., Iio G.H. Closed superficial femoral artery endarterectomy: a 2-year follow up. Cardiovasc Surg. 1997; 5: 398-400). Primary assisted patency for 33 months 88% (Rosenthal D, Martin JD, Schubart PJ, Wellons ED. Remote. superficial femoral artery endarterectomy. J Cardiovasc Surg. (Torino) 2004; 45: 185-192). The length of the occlusion is not a limitation to the use of remote endarterectomy. Primary patency at 31 months was 60%.
- Being tested
- Angioplasty with stenting of the femoral artery, Open surgery
- Keywords
- remote endarterectomy, Angioplasty with stenting of the superficial femoral artery
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 expandable or self-expanding) of all the extension is mounted.
Open surgeryProcedure or surgery
Performed open endarterectomy of the common, deep, initial of superficial femoral artery. Proximal plaque exfoliate as far as possible in the superficial femoral artery. After that, the translational and rotational motions loops under fluoroscopic guidance, continuing detachment of plaque in the antegrade direction to the distal end of plaque. Plastic of arteriotomy wounds performed patches of ksenoperikard treated with epoxy compounds. Control patency of the arterial vessel is performed intraoperatively by X-ray angiography. When rendering residual stenosis or intimal dissection, limiting blood flow, complemented by endovascular intervention plasticity.
| Study group | Role | What they receive |
|---|---|---|
| Stenting of the femoral artery | Active comparator | A standard endovascular treatment of the steno-occlusive lesion in femoro-popliteal arterial segment. Receives: Procedure: Angioplasty with stenting of the femoral artery |
| Open surgery | Experimental | Performed open endarterectomy of the common, deep, initial of superficial femoral artery. Delamination factory complex into the lumen of the loop. After that, the translational and rotational motions loops under fluoroscopic guidance, continuing detachment of plaque in the antegrade direction to the distal end of plaque. Plastic arteriotomnyh wounds performed patches of ksenoperikard treated with epoxy compounds. Control patency of the arterial bed is performed intraoperatively by X-ray angiography. Receives: Procedure: Open surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of lumen in target vessel
Measured: Baseline, 3 days after the operation, 6 month, 12 month, 2, 3 years
Secondary outcomes (3)
Number of participants with a successful procedure of revascularization.
Measured: During the operation.
Number of participants with complications during the operation.
Measured: During the operation.
Number of participants with limb salvage
Measured: Baseline, 3 days after the operation, 6 month, 12 month, 2, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Steno-occlusive Desease of Femoro-popliteal Arterial SegmentStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 174 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, cientific-Research Institute of Circulation Pathology named after Academician E. Meshalkin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948166
- Sponsor's protocol ID
- N-RICP-468
- Status last verified
- May 2017
- First submitted
- 25 Sep 2016
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Trial of the Remote Endarterectomy and the Femoral Arteries Endovascular Treatments in Patients With the Femoral Artery Occlusive Disease (TASC C, D)
- ClinicalTrials.gov ID
- NCT02948166
- Acronym / sponsor ID
- N-RICP-468
- Keywords
- remote endarterectomy, Angioplasty with stenting of the superficial femoral artery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Jan 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 28 Oct 2016 (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: remote endarterectomy vs. stenting of the superficial femoral artery cin patients with steno-occlusive lesion of the femoro-popliteal segment of TASC C, D
Detailed description
Reported local percutaneous angioplasty and stenosis of femoral popliteal arteries indicate that the primary technical and clinical success above 95%. The technical success of recanalization of long occlusions femoral arteries less than 80%. Improvement of endovascular equipment designed for the treatment of total occlusions, increases the technical success of recanalization. The materials of the TASC II summarizes the results of several large studies that presented data on the operated segment artery patency at 56-73,7% within 2 years of observation. An alternative method of revascularization own femoral artery is remote endarterectomy. The two-year primary patency at remote endarterectomy is 86% (Moll F.L., Iio G.H. Closed superficial femoral artery endarterectomy: a 2-year follow up. Cardiovasc Surg. 1997; 5: 398-400). Primary assisted patency for 33 months 88% (Rosenthal D, Martin JD, Schubart PJ, Wellons ED. Remote. superficial femoral artery endarterectomy. J Cardiovasc Surg. (Torino) 2004; 45: 185-192). The length of the occlusion is not a limitation to the use of remote endarterectomy. Primary patency at 31 months was 60%.
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 treatment of the steno-occlusive lesion in femoro-popliteal arterial segment. |
| Open surgery | Experimental | Procedure: Open surgeryPerformed open endarterectomy of the common, deep, initial of superficial femoral artery. Delamination factory complex into the lumen of the loop. After that, the translational and rotational motions loops under fluoroscopic guidance, continuing detachment of plaque in the antegrade direction to the distal end of plaque. Plastic arteriotomnyh wounds performed patches of ksenoperikard treated with epoxy compounds. Control patency of the arterial bed is performed intraoperatively by X-ray angiography. |
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 femoral artery 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 expandable or self-expanding) of all the extension is mounted. | Procedure or surgery | Stenting of the femoral artery |
| Open surgeryPerformed open endarterectomy of the common, deep, initial of superficial femoral artery. Proximal plaque exfoliate as far as possible in the superficial femoral artery. After that, the translational and rotational motions loops under fluoroscopic guidance, continuing detachment of plaque in the antegrade direction to the distal end of plaque. Plastic of arteriotomy wounds performed patches of ksenoperikard treated with epoxy compounds. Control patency of the arterial vessel is performed intraoperatively by X-ray angiography. When rendering residual stenosis or intimal dissection, limiting blood flow, complemented by endovascular intervention plasticity. | Procedure or surgery | Open surgery |
Primary outcome
the change of lumen in target vessel
Time frame: Baseline, 3 days after the operation, 6 month, 12 month, 2, 3 years
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: Baseline, 3 days after the operation, 6 month, 12 month, 2, 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
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
cientific-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 study testing Angioplasty with stenting of the femoral artery and Open surgery in people with Steno-occlusive Desease of Femoro-popliteal Arterial Segment, 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 5 May 2017. 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 Artem Rabtsun (+79137078354, a_rabtsun@meshalkin.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of lumen in target vessel (time frame: Baseline, 3 days after the operation, 6 month, 12 month, 2, 3 years). 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 5 May 2017.