Femoral Artery OcclusionNCT03142347
Remote Endarterectomy vs Remote Endarterectomy + Drug Coated Balloon (DCB) Angioplasty in Patients With the Femoral Artery Occlusive Disease
A study testing Remote endarterectomy and Remote endarterectomy + DCB balloon in people with Femoral Artery Occlusion, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
Comparison effectiveness two methods revascularization of the superficial femoral artery: remote endarterectomy vs. remote endarterectomy supplemented DCB angioplasty in patients with steno-occlusive lesion of the femoro-popliteal segment of TASCII D Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Femoral Artery Occlusion
- What is being tested?
- Remote endarterectomy and Remote endarterectomy + DCB balloon
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- Jan 2017to 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 New York Heart Association (NYHA) classification.
- Decompensated chronic "pulmonary" heart
- Severe hepatic or renal failure (bilirubin> 35 mmol / l, glomerular filtration rate <60 mL / min);
- Polyvalent drug allergy
- Cancer in the terminal stage with a life expectancy less than 6 months;
- Acute ischemic
- Expressed aortic calcification tolerant to remote endarterectomy
- 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: Remote Endarterectomy vs Remote Endarterectomy Supplement DCB Balloon Angioplasty in Patients With the Femoral Artery Occlusive Disease (TASCII D)
Comparison effectiveness two methods revascularization of the superficial femoral artery: remote endarterectomy vs. remote endarterectomy supplemented DCB angioplasty in patients with steno-occlusive lesion of the femoro-popliteal segment of TASCII D
Read the detailed description
Given that more and more devices appear to deliver cytotoxic drugs into the depth of atherosclerotic plaque, it is interesting to study the effect of these drugs when applied directly after plaque removal.
- Conditions
- Femoral Artery Occlusion
- Being tested
- Remote endarterectomy, Remote endarterectomy + DCB balloon
- Keywords
- remote endarterectomy, DCB balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote endarterectomyProcedure 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 xenopericardium. 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.
Remote endarterectomy + DCB balloonProcedure 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 xenopericardium. And balloon angioplasty of superficial femoral artery with DCB balloon is perform. 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 |
|---|---|---|
| Remote endarterectomy | Active comparator | Open endarterectomy of the common, deep, initial of superficial femoral artery was performed. 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 arteriotomy wounds performed patches of xenopericardium. Control patency of the arterial lumen is performed intraoperatively by X-ray angiography. Receives: Procedure: Remote endarterectomy |
| Remote endarterectomy + DCB balloon | Experimental | Open endarterectomy of the common, deep, initial of superficial femoral artery was performed. 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 arteriotomy wounds performed patches of xenopericardium. And balloon angioplasty of superficial femoral artery with DCB balloon is perform. Control patency of the arterial lumen is performed intraoperatively by X-ray angiography. Receives: Procedure: Remote endarterectomy + DCB balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of lumen in target vessel
stenosis or occlusions
Measured: Baseline, 3 days after the operation, 6 month, 12 month, 2 years
Secondary outcomes (3)
Vessel wall thickness
mm
Measured: 3 days after the operation, 6 month, 12 month, 2 years
Number of participants with limb salvage
Measured: 3 days after the operation, 6 month, 12 month, 2 years
Number of participants with complications in long-term period after the operation.
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 posted5 May 2017
- Study startJan 2017
- 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 Femoral Artery OcclusionStudies 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
- 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, cientific-Research Institute of Circulation Pathology named after Academician E. Meshalkin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142347
- Sponsor's protocol ID
- N-RICP-469
- Status last verified
- May 2017
- First submitted
- 3 May 2017
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- Remote Endarterectomy vs Remote Endarterectomy Supplement DCB Balloon Angioplasty in Patients With the Femoral Artery Occlusive Disease (TASCII D)
- ClinicalTrials.gov ID
- NCT03142347
- Acronym / sponsor ID
- N-RICP-469
- Conditions
- Femoral Artery Occlusion
- Keywords
- remote endarterectomy, DCB balloon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 5 May 2017 (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.
Comparison effectiveness two methods revascularization of the superficial femoral artery: remote endarterectomy vs. remote endarterectomy supplemented DCB angioplasty in patients with steno-occlusive lesion of the femoro-popliteal segment of TASCII D
Detailed description
Given that more and more devices appear to deliver cytotoxic drugs into the depth of atherosclerotic plaque, it is interesting to study the effect of these drugs when applied directly after plaque removal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote endarterectomy | Active comparator | Procedure: Remote endarterectomyOpen endarterectomy of the common, deep, initial of superficial femoral artery was performed. 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 arteriotomy wounds performed patches of xenopericardium. Control patency of the arterial lumen is performed intraoperatively by X-ray angiography. |
| Remote endarterectomy + DCB balloon | Experimental | Procedure: Remote endarterectomy + DCB balloonOpen endarterectomy of the common, deep, initial of superficial femoral artery was performed. 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 arteriotomy wounds performed patches of xenopericardium. And balloon angioplasty of superficial femoral artery with DCB balloon is perform. Control patency of the arterial lumen 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 (8 listed)
- Chronic heart failure of III-IV functional class by New York Heart Association (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 |
|---|---|---|
| Remote endarterectomyPerformed 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 xenopericardium. 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 | Remote endarterectomy |
| Remote endarterectomy + DCB balloonPerformed 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 xenopericardium. And balloon angioplasty of superficial femoral artery with DCB balloon is perform. 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 | Remote endarterectomy + DCB balloon |
Primary outcome
the change of lumen in target vessel
Time frame: Baseline, 3 days after the operation, 6 month, 12 month, 2 years
stenosis or occlusions
3 secondary outcomes
Vessel wall thickness
Time frame: 3 days after the operation, 6 month, 12 month, 2 years
Number of participants with limb salvage
Time frame: 3 days after the operation, 6 month, 12 month, 2 years
Number of participants with complications in long-term period after the operation.
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 5 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
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 Remote endarterectomy and Remote endarterectomy + DCB balloon in people with Femoral Artery Occlusion, 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 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 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 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.