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Carotid Aneurysm Registry (CAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02229370
Recruitment Status : Recruiting
First Posted : September 1, 2014
Last Update Posted : December 11, 2015
Information provided by (Responsible Party):
Gert Jan de Borst, UMC Utrecht

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.

Condition or disease
Extracranial Carotid Artery Aneurysm

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Extracranial Carotid Artery Aneurysm Registry
Study Start Date : June 2014
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

all patients diagnosed with an extracranial carotid artery aneurysm

Primary Outcome Measures :
  1. aneurysms related symptoms [ Time Frame: 5 years ]
    Aneurysm related symptoms such as ipsilateral stroke, TIA or compression. Disability is assessed by the Rankin scale.

Secondary Outcome Measures :
  1. number of peri- and postoperative complications. [ Time Frame: 30 days ]
    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.

Biospecimen Retention:   Samples With DNA
blood withdrawel

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02229370

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Contact: Gert Jan de Borst, MD, PhD +31-88-7556965

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University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3508 GA
Contact: Gert Jan de Borst, MD, PhD    +31-88-7556965   
Sponsors and Collaborators
UMC Utrecht
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Principal Investigator: Gert Jan de Borst, MD, PhD UMC Utrecht

Additional Information:
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Responsible Party: Gert Jan de Borst, MD PhD, UMC Utrecht Identifier: NCT02229370     History of Changes
Other Study ID Numbers: CAR2014
First Posted: September 1, 2014    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: December 2015
Keywords provided by Gert Jan de Borst, UMC Utrecht:
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases