Carotid Artery DiseasesAGICSNCT06528717
The Role of Maintaining External Carotid Artery Flow in Graft Interposition After Carotid Endarterectomy
An observational study of Carotid Artery Diseases and Stroke, run by Institute for Cardiovascular Diseases Dedinje at 1 site in Serbia.
Trial summary
Analyzing results of carotid graft interposition with and without flow preservation through external carotid artery after endarterectomy. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Carotid Artery Diseases, Stroke, Carotid Atherosclerosis
- What is being tested?
- Carotid graft interposition
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteSerbia
- Study dates
- 12 Jun 2024to 30 Dec 2024
- Phase
- Observational
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent carotid artery surgery due to atherosclerotic symptomatic and asymptomatic disease had graft interposition conducted due to unsuccessful endarterectomy.
Who may be able to join
- symptomatic carotid stenosis (> 50%)
- unilateral asymptomatic carotid stenosis (> 60%)
- bilateral asymptomatic carotid stenosis (> 60%)
Who cannot join
- carotid restenosis
- "major surgery" in previous 6 months
- previous brain trauma or surgery
- malignant disease
- epilepsy
- carotid artery aneurysm
Trial locations and contacts
1 site in 1 country.
Jovan Petrovic, MD contact
Serbia1 site, 1 recruiting
- Recruiting
Institute for Cardiovascular Diseases Dedinje
Belgrade, 11000
Slobodan Pesic, 00381616303360, spesic90@gmail.com
About this study
Analyzing results of carotid graft interposition with and without flow preservation through external carotid artery after endarterectomy.
Read the detailed description
Surgical and endovascular treatment have been shown as effective treatment modalities in symptomatic and asymptomatic patients at high risk of stroke on medical therapy with significant carotid artery stenosis. Eversion carotid endarterectomy (eCEA) has proven effective as a surgical treatment modality. In highly selected instances carotid bypass may be indicated as a bailout procedure or primarily as a preoperatively planned maneuver. Usually, the decision for substitution of carotid bifurcation with a synthetic graft is made due to an extensive, severe atherosclerotic process on the distal part of the extracranial internal carotid artery, the presence of uncontrollable atherosclerotic plaque after endarterectomy, and in cases when an exceptionally thin artery wall remains after endarterectomy.
Several techniques have been described for substituting carotid bifurcation with a synthetic graft. The most common technique involves complete resection and excision of the carotid bifurcation and reconstruction with graft interposition between the undiseased segment of the common carotid artery (CCA) proximally and the internal carotid artery (ICA) distally by creating proximal and distal end-to-end anastomoses. This technique requires ligation and exclusion of the external carotid (ECA) and the superior thyroid artery from circulation. The less common techniques that preserve flow through the external carotid artery are performed as a primary option for treatment without previous endarterectomy and are seldom applied. Currently, there are no recommendations regarding the administration of carotid bypass, nor comparisons of these techniques.
In this study, the investigators are comparing a technique with graft interposition between endarterectomized CCA (creation of side-to-end anastomosis) and the distal segment of the ICA (end-to-end anastomosis) after failure of eCEA to provide technical success with the described common interposition by end-to-end anastomoses proximally and distally. Therefore, the role of flow preservation through the ECA could be defined.
- Conditions
- Carotid Artery Diseases, Stroke, Carotid Atherosclerosis
- Being tested
- Carotid graft interposition
- Medical subject headings
- Carotid Artery Diseases, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid graft interpositionProcedure or surgery
Also called Carotid artery graft replacement, Carotid replacement with Dacron graft
In patients with extensive atherosclerotic carotid disease, when endarterectomy isn't feasible, replacement of the carotid artery with a graft is needed. Graft interposition can be performed either by end-to-end proximal and distal anastomoses in the undiseased common and internal carotid artery with ligation of the external carotid artery, or by side-to-end proximal anastomosis on the origin of the internal carotid artery and end-to-end distal anastomosis on the internal carotid artery with flow preservation in the external carotid artery.
| Study group | Role | What they receive |
|---|---|---|
| ECA flow preserved group | Patients with carotid graft interposition after endarterectomy of the common carotid artery and external carotid artery with preserved flow through the external carotid artery by side-to-end proximal anastomosis. Receives: Procedure: Carotid graft interposition | |
| Ligated ECA group | Patients with carotid graft interposition and end-to-end anastomoses on the undiseased segments of the common (proximally) and internal (distally) carotid artery, with ligation of the external carotid artery. Receives: Procedure: Carotid graft interposition |
What is being measured
The primary outcome is the main question the study is designed to answer.
periprocedural stroke and death
onset of new neurological deficit or death during perioperative period
Measured: 30 days
myocardial infarction
development of new acute coronary events during perioperative period
Measured: 30 days
stroke ipsilateral to the procedure
development of new neurological events that are pathophysiological atributable to the operated side
Measured: through study completion, an average of 2 years
Secondary outcomes (3)
restenosis rate
restenosis after graft placement diagnosed by color Doppler sonographic examination or by multiplanar detection computerized tomography angiography
Measured: through study completion, an average of 2 years
graft patency
primary and primary assisted
Measured: through study completion, an average of 2 years
patient survival
defining cause of death
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start12 Jun 2024
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Cardiovascular Diseases Dedinje
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Slobodan Pesic, Institute for Cardiovascular Diseases Dedinje
- Investigators
- Srdjan Babic, MD PhD, Study director, Institute for Cardiovascular Diseases Dedinje
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528717
- Sponsor's protocol ID
- 3586
- Acronym
- AGICS
- Status last verified
- Jul 2024
- First submitted
- 20 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Timaran CH, McKinsey JF, Schneider PA, Littooy F. Reporting standards for carotid interventions from the Society for Vascular Surgery. J Vasc Surg. 2011 Jun;53(6):1679-95. doi: 10.1016/j.jvs.2010.11.122. No abstract available.
PubMed 21609800
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Maintaining External Carotid Artery Flow in Graft Interposition After Carotid Endarterectomy
- ClinicalTrials.gov ID
- NCT06528717
- Acronym / sponsor ID
- AGICS / 3586
- Conditions
- Carotid Artery Diseases, Stroke, Carotid Atherosclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Institute for Cardiovascular Diseases DedinjeUniversity, hospital or other
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 30 Jul 2024 (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.
Analyzing results of carotid graft interposition with and without flow preservation through external carotid artery after endarterectomy.
Detailed description
Surgical and endovascular treatment have been shown as effective treatment modalities in symptomatic and asymptomatic patients at high risk of stroke on medical therapy with significant carotid artery stenosis. Eversion carotid endarterectomy (eCEA) has proven effective as a surgical treatment modality. In highly selected instances carotid bypass may be indicated as a bailout procedure or primarily as a preoperatively planned maneuver. Usually, the decision for substitution of carotid bifurcation with a synthetic graft is made due to an extensive, severe atherosclerotic process on the distal part of the extracranial internal carotid artery, the presence of uncontrollable atherosclerotic plaque after endarterectomy, and in cases when an exceptionally thin artery wall remains after endarterectomy.
Several techniques have been described for substituting carotid bifurcation with a synthetic graft. The most common technique involves complete resection and excision of the carotid bifurcation and reconstruction with graft interposition between the undiseased segment of the common carotid artery (CCA) proximally and the internal carotid artery (ICA) distally by creating proximal and distal end-to-end anastomoses. This technique requires ligation and exclusion of the external carotid (ECA) and the superior thyroid artery from circulation. The less common techniques that preserve flow through the external carotid artery are performed as a primary option for treatment without previous endarterectomy and are seldom applied. Currently, there are no recommendations regarding the administration of carotid bypass, nor comparisons of these techniques.
In this study, the investigators are comparing a technique with graft interposition between endarterectomized CCA (creation of side-to-end anastomosis) and the distal segment of the ICA (end-to-end anastomosis) after failure of eCEA to provide technical success with the described common interposition by end-to-end anastomoses proximally and distally. Therefore, the role of flow preservation through the ECA could be defined.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECA flow preserved group | – | Procedure: Carotid graft interpositionPatients with carotid graft interposition after endarterectomy of the common carotid artery and external carotid artery with preserved flow through the external carotid artery by side-to-end proximal anastomosis. |
| Ligated ECA group | – | Procedure: Carotid graft interpositionPatients with carotid graft interposition and end-to-end anastomoses on the undiseased segments of the common (proximally) and internal (distally) carotid artery, with ligation of the external carotid artery. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent carotid artery surgery due to atherosclerotic symptomatic and asymptomatic disease had graft interposition conducted due to unsuccessful endarterectomy.
Key inclusion criteria (3 listed)
- symptomatic carotid stenosis (> 50%)
- unilateral asymptomatic carotid stenosis (> 60%)
- bilateral asymptomatic carotid stenosis (> 60%)
Key exclusion criteria (6 listed)
- carotid restenosis
- "major surgery" in previous 6 months
- previous brain trauma or surgery
- malignant disease
- epilepsy
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 |
|---|---|---|
| Carotid graft interpositionAlso: Carotid artery graft replacement, Carotid replacement with Dacron graftIn patients with extensive atherosclerotic carotid disease, when endarterectomy isn't feasible, replacement of the carotid artery with a graft is needed. Graft interposition can be performed either by end-to-end proximal and distal anastomoses in the undiseased common and internal carotid artery with ligation of the external carotid artery, or by side-to-end proximal anastomosis on the origin of the internal carotid artery and end-to-end distal anastomosis on the internal carotid artery with flow preservation in the external carotid artery. | Procedure or surgery | ECA flow preserved group, Ligated ECA group |
Primary outcome
periprocedural stroke and death
Time frame: 30 days
onset of new neurological deficit or death during perioperative period
myocardial infarction
Time frame: 30 days
development of new acute coronary events during perioperative period
stroke ipsilateral to the procedure
Time frame: through study completion, an average of 2 years
development of new neurological events that are pathophysiological atributable to the operated side
3 secondary outcomes
restenosis rate
Time frame: through study completion, an average of 2 years
graft patency
Time frame: through study completion, an average of 2 years
patient survival
Time frame: through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Background: PubMed 21609800Timaran CH, McKinsey JF, Schneider PA, Littooy F. Reporting standards for carotid interventions from the Society for Vascular Surgery. J Vasc Surg. 2011 Jun;53(6):1679-95. doi: 10.1016/j.jvs.2010.11.122. No abstract available.
- 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.
Jovan Petrovic, MD contact
Srdjan Babic, MD PhD study director
Institute for Cardiovascular Diseases Dedinje
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Diseases and Stroke, run by Institute for Cardiovascular Diseases Dedinje at 1 site in Serbia.
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 6 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 30 Jul 2024. 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 Serbia. 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 Slobodan Pesic, MD (00381616303360, spesic90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
periprocedural stroke and death (time frame: 30 days). 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?
On the ClinicalTrials.gov record for NCT06528717, which also lists 1 linked publication.
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 30 Jul 2024.