Clinical trial NCT02229370: Carotid Aneurysm Registry
Official title: Extracranial Carotid Artery Aneurysm Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Extracranial Carotid Artery Aneurysm
Keywords: extracranial
carotid
artery
aneurysm
registry
CAR
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2014-09-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participation in the CAR is intended for all subjects diagnosed with an extracranial carotid artery aneurysm irrespective of chosen treatment.

Brief summary: To prospectively collect data on ECAA we designed the Carotid Aneurysm Registry (CAR). The aim of this study is to collect data on ECAA and its treatment to assess the natural history of ECAA and the success and safety of different treatment strategies.

Detailed description: CAR is a prospective observational study, initiated by the Department of Vascular Surgery at University Medical Centre Utrecht (UMCU), The Netherlands. The study is descriptive in nature. The registry will be conducted according to the principles of the Declaration of Helsinki (64th WMA General Assembly, Fortaleza, Brazil, October 2013). The medical ethics committee of the UMCU has approved the study and all patients must give written informed consent before enrollment. Study enrolment is open to any patient diagnosed with an ECAA and ongoing.

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.

Eligibility criteria: Inclusion Criteria:

* Individual has one or more aneurysms of the extracranial carotid artery. Defined as 150% dilatation of the normal vessel diameter, or any saccular aneurysm.
* Individual is ≥18 years of age.
* Individual has signed informed consent

Exclusion Criteria:

* none

Primary outcomes:
measure: aneurysms related symptoms
timeFrame: 5 years
Secondary outcomes:
measure: number of peri- and postoperative complications.
timeFrame: 30 days
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: UMC Utrecht
name: Gert Jan de Borst, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.