Carotid Aneurysm Registry

Study Overview
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Brief Summary
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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
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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.

Official Title
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Extracranial Carotid Artery Aneurysm Registry

Conditions
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Extracranial Carotid Artery Aneurysm

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ECAA<br>all patients diagnosed with an extracranial carotid artery aneurysm | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| aneurysms related symptoms | Aneurysm related symptoms such as ipsilateral stroke, TIA or compression. Disability is assessed by the Rankin scale. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of peri- and postoperative complications. | Treatment safety includes peri- and postoperative complications and registration of reinterventions performed within 30days after initial treatment. Complications include peripheral nerve dysfunction, local hematoma or infection, local pain or headache, TIA, stroke, local bleeding or aneurysm rupture and all-cause mortality. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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extracranial, carotid, artery, aneurysm, registry, CAR