Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2014-06-30
2025-12-31
Brief Summary
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Detailed Description
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Enrollment criteria: Participation in the CAR is intended for all subjects diagnosed with an ECAA irrespective of chosen treatment. Aneurysms are defined as 150% dilatation of the normal vessel diameter, or any saccular aneurysm. To be included, aneurysms must be located in the CCA, the external carotid artery or in the extracranial part of the ICA.To be included in the registry, patients need to be 18 years old. There are no additional exclusion criteria.
Intervention and follow-up:CAR does not interfere with the physician's treatment decision. Follow-up visits and imaging studies are scheduled as usual in their clinical practice, as this study does also not interfere with or influence the follow-up regimen.
Study endpoints:The primary endpoint of the CAR is freedom from aneurysm related symptoms at 30 days and at mid- and longterm follow-up. The secondary endpoint comprises treatment safety.
Endpoint monitoring:An endpoint adjudication committee, consisting of clinical experts, is set up to harmonize and standardize endpoint assessment and to determine whether the endpoints meet described criteria. This committee will review important subjective endpoints reported by trial investigators. The members of this committee are blinded to the treatment regime.
Data collection and monitoring: Data collected will be recorded through a web-based case report form (CRF). Data will be collected at baseline, at the moment of intervention, at the 30-day (or first postoperative) visit and during the follow-up phase. Data will remain at the UMCU in a secure environment.
This registry is a multicenter study. Statistical analysis: Statistical analyses will be performed using SPSS software.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ECAA
all patients diagnosed with an extracranial carotid artery aneurysm
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Individual is ≥18 years of age.
* Individual has signed informed consent
Exclusion Criteria
18 Years
120 Years
ALL
No
Sponsors
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UMC Utrecht
OTHER
Responsible Party
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Gert Jan de Borst
MD PhD
Principal Investigators
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Gert Jan de Borst, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht
Locations
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University Medical Center Utrecht
Utrecht, Utrecht, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Gert Jan de Borst, MD, PhD
Role: primary
References
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Welleweerd JC, Bots ML, Kappelle LJ, Rinkel GJ, Ruigrok YM, Baas AF, van der Worp HB, Vergouwen MD, Bleys RL, Hendrikse J, Lo TR, Moll FL, de Borst GJ. Rationale and design of the extracranial Carotid artery Aneurysm Registry (CAR). J Cardiovasc Surg (Torino). 2018 Oct;59(5):692-698. doi: 10.23736/S0021-9509.16.08637-7. Epub 2015 Feb 6.
Welleweerd JC, de Borst GJ; Carotid Aneurysm Registry Project Group. Extracranial carotid artery aneurysm: optimal treatment approach. Eur J Vasc Endovasc Surg. 2015 Mar;49(3):235-6. doi: 10.1016/j.ejvs.2014.11.007. Epub 2014 Dec 9. No abstract available.
Welleweerd JC, Nelissen BG, Koole D, de Vries JP, Moll FL, Pasterkamp G, Vink A, de Borst GJ. Histological analysis of extracranial carotid artery aneurysms. PLoS One. 2015 Jan 30;10(1):e0117915. doi: 10.1371/journal.pone.0117915. eCollection 2015.
Welleweerd JC, de Borst GJ, de Groot D, van Herwaarden JA, Lo RT, Moll FL. Bare metal stents for treatment of extracranial internal carotid artery aneurysms: long-term results. J Endovasc Ther. 2015 Feb;22(1):130-4. doi: 10.1177/1526602814566405.
Welleweerd JC, Moll FL, de Borst GJ. Technical options for the treatment of extracranial carotid aneurysms. Expert Rev Cardiovasc Ther. 2012 Jul;10(7):925-31. doi: 10.1586/erc.12.61.
Related Links
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Click here for more information about this study: Carotid Aneurysm Registry
Other Identifiers
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CAR2014
Identifier Type: -
Identifier Source: org_study_id