NCT02229370

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 1, 2014

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
6.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 11, 2015

Status Verified

December 1, 2015

Enrollment Period

5 years

First QC Date

August 26, 2014

Last Update Submit

December 10, 2015

Conditions

Extracranial Carotid Artery Aneurysm

Keywords

extracranialcarotidarteryaneurysmregistryCAR

Outcome Measures

Primary Outcomes (1)

  • aneurysms related symptoms

    Aneurysm related symptoms such as ipsilateral stroke, TIA or compression. Disability is assessed by the Rankin scale.

    5 years

Secondary Outcomes (1)

  • number of peri- and postoperative complications.

    30 days

Study Arms (1)

ECAA

all patients diagnosed with an extracranial carotid artery aneurysm

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participation in the CAR is intended for all subjects diagnosed with an extracranial carotid artery aneurysm irrespective of chosen treatment.

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Utrecht

Utrecht, Utrecht, 3508 GA, Netherlands

RECRUITING

Related Publications (5)

  • 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.

    PMID: 25658976BACKGROUND

  • 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.

    PMID: 25500055BACKGROUND

  • 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.

    PMID: 25635813BACKGROUND

  • 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.

    PMID: 25775693BACKGROUND

  • 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.

    PMID: 22908925BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

blood withdrawel

MeSH Terms

Conditions

Aneurysm

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Gert Jan de Borst, MD, PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gert Jan de Borst, MD, PhD

CONTACT

+31-88-7556965g.j.deBorst-2@umcutrecht.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

August 26, 2014

First Posted

September 1, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2019

Study Completion

December 1, 2025

Last Updated

December 11, 2015

Record last verified: 2015-12

Locations

NL(1)