Carotid Aneurysm Registry (CAR)
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|ClinicalTrials.gov Identifier: NCT02229370|
Recruitment Status : Recruiting
First Posted : September 1, 2014
Last Update Posted : December 11, 2015
|Condition or disease|
|Extracranial Carotid Artery Aneurysm|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|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|
all patients diagnosed with an extracranial carotid artery aneurysm
- aneurysms related symptoms [ Time Frame: 5 years ]Aneurysm related symptoms such as ipsilateral stroke, TIA or compression. Disability is assessed by the Rankin scale.
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT02229370
|Contact: Gert Jan de Borst, MD, PhD||+31-88-7556965||g.j.deBorstfirstname.lastname@example.org|
|University Medical Center Utrecht||Recruiting|
|Utrecht, Netherlands, 3508 GA|
|Contact: Gert Jan de Borst, MD, PhD +31-88-7556965 g.j.deBorstemail@example.com|
|Principal Investigator:||Gert Jan de Borst, MD, PhD||UMC Utrecht|