Stenosis, Internal Carotid ArteryNCT03027752
Pilot Study of Autoarterial Remodeling of Bifurcation of the Common Carotid Artery
A study testing Operation carotid endarterectomy with plastic of xenopericardial patch and New method of operation сarotid endarterectomy with autoarterial remodeling of bifurcation CCA in people with Stenosis, Internal Carotid Artery, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
Comparison of two methods for revascularization of the bifurcation of common carotid artery: carotid endarterectomy with longitudinal incision carotid endarterectomy patch angioplasty compared with new technique of carotid endarterectomy with autoarterial remodeling of bifurcation of the common carotid artery Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stenosis, Internal Carotid Artery
- What is being tested?
- Operation carotid endarterectomy with plastic of xenopericardial patch and New method of operation сarotid endarterectomy with autoarterial remodeling of bifurcation CCA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- Dec 2016to Oct 2018
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stenotic lesions of the extracranial part of carotid arteries requiring surgical treatment according to national treatment guidelines (asymptomatic ICA stenosis more than 70% symptomatic ICA stenosis more than 65%)
- the length of the atherosclerotic plaques in the ICA than 1 cm
- personally signed Informed consent for participation in the study
Who cannot join
- Chronic heart failure III-IV functional class NYHA classification
- Chronic decompensated "lung" heart
- Decompensated diseases of endocrine organs (diabetes glycemia more than 10 mmol/l)
- Severe hepatic or renal insufficiency (bilirubin >80 mmol/l, creatinine >200 mmol/l)
- Polyvalent drug Allergy;
- Malignant tumor in the terminal stage with life expectancy of up to 6 months;
Show all 11Show fewer
- Acute disruption of cerebral blood flow
- Extensive occlusion of the internal carotid artery.
- Exacerbation of systemic diseases.
- Pregnancy and lactation.
- The refusal of a patient to sign informed consent for participation in the study
Trial locations and contacts
1 site in 1 country.
Russia1 site
Novosibirsk Research Institute of Circulation Pathology
Novosibirsk, 630055
About this study
Official title: The New Technique of Carotid Endarterectomy With Autoarterial Remodeling of Bifurcation of the Common Carotid Artery.
Comparison of two methods for revascularization of the bifurcation of common carotid artery: carotid endarterectomy with longitudinal incision carotid endarterectomy patch angioplasty compared with new technique of carotid endarterectomy with autoarterial remodeling of bifurcation of the common carotid artery
- Conditions
- Stenosis, Internal Carotid Artery
- Being tested
- Operation carotid endarterectomy with plastic of xenopericardial patch, New method of operation сarotid endarterectomy with autoarterial remodeling of bifurcation CCA
- Keywords
- carotid endaretectomy
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operation carotid endarterectomy with plastic of xenopericardial patchProcedure or surgery
Under local anesthesia Sol.Novocaini 0.25%, wires or endotracheal anesthesia using the standard access the bifurcation of the common carotid artery, internal carotid artery, isolated on identical distance external carotid artery. Common carotid artery cut then performed a longitudinal arteriotomy on the front of the anterior surface of the internal carotid artery. Under the visual control performs a sequence of endarterectomy of the internal carotid artery. Plastic arteriotomy performed patche of ksenoperikardial (Kemperiplas-Neo) treated with epoxy compounds.
New method of operation сarotid endarterectomy with autoarterial remodeling of bifurcation CCAProcedure or surgery
Under local anesthesia Sol.Novocaini 0.25%, or endotracheal anesthesia using the standard access the bifurcation of the common carotid artery, internal carotid artery, isolated on identical distance external carotid artery. Carotid glomus separated and moves downward and backward bifurcation of the common carotid artery. External carotid artery is cut off at an angle of 45º from the mouth with a portion of the common carotid artery, then performed a longitudinal arteriotomy on the front of the medial surface of the internal carotid and posterior-lateral surface of the external carotid artery. Under the visual control performs a sequence of endarterectomy of the internal and external carotid arteries. The final recovery of the arteries is performed by crosslinking of their walls with each other in a side by side type between the internal and external carotid arteries 6/0 Polypropylene thread with two needles.
| Study group | Role | What they receive |
|---|---|---|
| carotid endarterectomy patch angioplasty | Active comparator | Carotid endarterectomy with longitudinal incision carotid endarterectomy patch angioplasty Receives: Procedure: Operation carotid endarterectomy with plastic of xenopericardial patch |
| Carotid endarterectomy with autoarterial remodeling | Experimental | Carotid endarterectomy with autoarterial remodeling of bifurcation of the common carotid artery Receives: Procedure: New method of operation сarotid endarterectomy with autoarterial remodeling of bifurcation CCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke or TIA
according to the examination of neurologist
Measured: throughout 1 year
Secondary outcomes (11)
Restenosis
The percentage narrowing of the lumen at the bifurcation of the carotid artery at 1 year after surgery according to the ultrasound
Measured: 1 year
Restenosis
The percentage narrowing of the lumen at the bifurcation of the carotid artery at 6 months after surgery according to the ultrasound
Measured: 6 months
paresis of the cranial nerve
Neurological status after surgical treatment according to the examination of neurologist
Measured: up to 1 weeks
The linear flow velocity in the region of the carotid artery bifurcation
The linear velocity of blood flow in the bifurcation of the carotid artery at 2-3 days after surgery according to the ultrasound
Measured: 3rd day
The linear flow velocity in the region of the carotid artery bifurcation
The linear velocity of blood flow in the bifurcation of the carotid artery after 6 months according to the ultrasound
Measured: 6 months
The linear flow velocity in the region of the carotid artery bifurcation
The linear velocity of blood flow in the bifurcation of the carotid artery after 1 year according to the ultrasound
Measured: 1 year
bleeding
30 days after surgery
Measured: 1 month
Stenosis
The percentage narrowing of the lumen at the bifurcation of the carotid artery at 2-3 days after surgery according to the ultrasound
Measured: 3rd day
Oxygenation of the brain
according to transcranial oximetry
Measured: during the surgical intervention
Oxygenation of the brain
according to transcranial oximetry
Measured: 6 months
Oxygenation of the brain
according to transcranial oximetry
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startDec 2016
- Primary completion30 Sep 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stenosis, Internal Carotid ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
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
- NCT03027752
- Sponsor's protocol ID
- N-RICP-346
- Status last verified
- Aug 2016
- First submitted
- 15 Jan 2017
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The New Technique of Carotid Endarterectomy With Autoarterial Remodeling of Bifurcation of the Common Carotid Artery.
- ClinicalTrials.gov ID
- NCT03027752
- Acronym / sponsor ID
- N-RICP-346
- Conditions
- Stenosis, Internal Carotid Artery
- Keywords
- carotid endaretectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Dec 2016 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 23 Jan 2017 (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 bifurcation of common carotid artery: carotid endarterectomy with longitudinal incision carotid endarterectomy patch angioplasty compared with new technique of carotid endarterectomy with autoarterial remodeling of bifurcation of the common carotid artery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| carotid endarterectomy patch angioplasty | Active comparator | Procedure: Operation carotid endarterectomy with plastic of xenopericardial patchCarotid endarterectomy with longitudinal incision carotid endarterectomy patch angioplasty |
| Carotid endarterectomy with autoarterial remodeling | Experimental | Procedure: New method of operation сarotid endarterectomy with autoarterial remodeling of bifurcation CCACarotid endarterectomy with autoarterial remodeling of bifurcation of the common carotid artery |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- stenotic lesions of the extracranial part of carotid arteries requiring surgical treatment according to national treatment guidelines (asymptomatic ICA stenosis more than 70% symptomatic ICA stenosis more than 65%)
- the length of the atherosclerotic plaques in the ICA than 1 cm
- personally signed Informed consent for participation in the study
Key exclusion criteria (11 listed)
- Chronic heart failure III-IV functional class NYHA classification
- Chronic decompensated "lung" heart
- Decompensated diseases of endocrine organs (diabetes glycemia more than 10 mmol/l)
- Severe hepatic or renal insufficiency (bilirubin >80 mmol/l, creatinine >200 mmol/l)
- Polyvalent drug Allergy;
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 |
|---|---|---|
| Operation carotid endarterectomy with plastic of xenopericardial patchUnder local anesthesia Sol.Novocaini 0.25%, wires or endotracheal anesthesia using the standard access the bifurcation of the common carotid artery, internal carotid artery, isolated on identical distance external carotid artery. Common carotid artery cut then performed a longitudinal arteriotomy on the front of the anterior surface of the internal carotid artery. Under the visual control performs a sequence of endarterectomy of the internal carotid artery. Plastic arteriotomy performed patche of ksenoperikardial (Kemperiplas-Neo) treated with epoxy compounds. | Procedure or surgery | carotid endarterectomy patch angioplasty |
| New method of operation сarotid endarterectomy with autoarterial remodeling of bifurcation CCAUnder local anesthesia Sol.Novocaini 0.25%, or endotracheal anesthesia using the standard access the bifurcation of the common carotid artery, internal carotid artery, isolated on identical distance external carotid artery. Carotid glomus separated and moves downward and backward bifurcation of the common carotid artery. External carotid artery is cut off at an angle of 45º from the mouth with a portion of the common carotid artery, then performed a longitudinal arteriotomy on the front of the medial surface of the internal carotid and posterior-lateral surface of the external carotid artery. Under the visual control performs a sequence of endarterectomy of the internal and external carotid arteries. The final recovery of the arteries is performed by crosslinking of their walls with each other in a side by side type between the internal and external carotid arteries 6/0 Polypropylene thread with two needles. | Procedure or surgery | Carotid endarterectomy with autoarterial remodeling |
Primary outcome
Stroke or TIA
Time frame: throughout 1 year
according to the examination of neurologist
11 secondary outcomes
Restenosis
Time frame: 1 year
Restenosis
Time frame: 6 months
paresis of the cranial nerve
Time frame: up to 1 weeks
The linear flow velocity in the region of the carotid artery bifurcation
Time frame: 3rd day
The linear flow velocity in the region of the carotid artery bifurcation
Time frame: 6 months
The linear flow velocity in the region of the carotid artery bifurcation
Time frame: 1 year
bleeding
Time frame: 1 month
Stenosis
Time frame: 3rd day
Oxygenation of the brain
Time frame: during the surgical intervention
Oxygenation of the brain
Time frame: 6 months
Oxygenation of the brain
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operation carotid endarterectomy with plastic of xenopericardial patch and New method of operation сarotid endarterectomy with autoarterial remodeling of bifurcation CCA in people with Stenosis, Internal Carotid Artery, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 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: finished, as of the sponsor's last update on 29 Oct 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke or TIA (time frame: throughout 1 year). 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 29 Oct 2018.