Carotid Aneurysm Registry
Carotid Aneurysm Registry
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.
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.
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