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Status unknownNCT02444832MACAARETUpdated May 15, 2015

Multicenter Retrospective Registry of Anterior Communicating Artery Aneurysms With Endovascular Therapy

An observational study in Intracranial Aneurysm, Anterior Communicating Artery Aneurysm and Cerebral Aneurysm, sponsored by Hospital Clinic of Barcelona. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-05-15.

Sponsored by Hospital Clinic of Barcelona · Observational

The sponsor has not verified this record recently (last verified May 2015), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
300
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Based on the anatomical features of the anterior Communicating artery complex, the investigators will analyze the outcome of the ACoA aneurysms treated by endovascular therapy.

The most common site of intracranial aneurysms is the anterior communicating artery (AcomA). AcomA aneurysms account for approximately one-fourth of all intracranial aneurysms.

Recent publications have addressed specifically the endovascular treatment of AcoA aneurysms. Furthermore, detailed anatomic characteristics and the effects of the multiple variations of the anterior communicating artery complex have scarcely been reported.

The hemodynamic factors play a fundamental role in the adequate treatment of aneurismal coiling.

The objective of our registry is to analyze the impact of morphological configuration of the anterior communicating artery complex and the results of coil embolization in AcoA aneurysms

02

Conditions studied

  • Intracranial Aneurysm
  • Anterior Communicating Artery Aneurysm
  • Cerebral Aneurysm
  • Aneurysm, Ruptured
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with Communicating Artery Aneurysm treated with endovascular coiling.

Inclusion criteria

  • Patient with Anterior Communicating Artery Aneurysm treated with endovascular coiling.

Exclusion criteria

Exclusion Criteria:

  • Patients without imaging follow up of at least 12 months after endovascular treatment.
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
300 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Effective Aneurysm Coiling (no residual cerebral aneurysm)

    Time frame: 1 year

Secondary outcomes

  1. All Cause Mortality

    Time frame: 1 year

  2. Neurological Outcome (classified with the Glasgow Outcome Scale, Rankin Scale)

    All patients will be classified with the Glasgow Outcome Scale, Rankin Scale.

    Time frame: 1 year

  3. Procedural device-related serious adverse events

    Time frame: 1 year

06

Study locations

1 of 1 sites recruiting
  • Hospital Clinic
    Barcelona, 08036, Spain
    • Federico Zarco, MD · Contact · fzarco@clinic.ub.es · 932 27 54 00
    • Federico · Contact
    • Federico Zarco, MD · Principal investigator
    • Antonio Lopez Rueda, MD · Principal investigator
    • Juan Macho Fernandez, MD · Sub investigator
    • Fernando Delgado, MD · Sub investigator
    • Alejandro González García, MD · Sub investigator
    • Mariano Werner, MD · Sub investigator
    • Oscar Chirife, MD · Sub investigator
    • Napoleón Macias, MD · Sub investigator
    • Luis San Roman, MD · Sub investigator
    • Jordi Blasco, MD · Sub investigator
    Recruiting
07

References and documents

Publications

  • Elias T, Ogungbo B, Connolly D, Gregson B, Mendelow AD, Gholkar A. Endovascular treatment of anterior communicating artery aneurysms: results of clinical and radiological outcome in Newcastle. Br J Neurosurg. 2003 Jun;17(3):278-86. doi: 10.1080/0268869031000153251. PubMed 14565533 ↗
  • Moret J, Pierot L, Boulin A, Castaings L, Rey A. Endovascular treatment of anterior communicating artery aneurysms using Guglielmi detachable coils. Neuroradiology. 1996 Nov;38(8):800-5. doi: 10.1007/s002340050352. PubMed 8957810 ↗
  • Birknes JK, Hwang SK, Pandey AS, Cockroft K, Dyer AM, Benitez RP, Veznedaroglu E, Rosenwasser RH. Feasibility and limitations of endovascular coil embolization of anterior communicating artery aneurysms: morphological considerations. Neurosurgery. 2006 Jul;59(1):43-52; discussion 43-52. doi: 10.1227/01.NEU.0000219220.25721.B9. PubMed 16823299 ↗
  • Molyneux AJ, Kerr RS, Yu LM, Clarke M, Sneade M, Yarnold JA, Sandercock P; International Subarachnoid Aneurysm Trial (ISAT) Collaborative Group. International subarachnoid aneurysm trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised comparison of effects on survival, dependency, seizures, rebleeding, subgroups, and aneurysm occlusion. Lancet. 2005 Sep 3-9;366(9488):809-17. doi: 10.1016/S0140-6736(05)67214-5. PubMed 16139655 ↗
08

Registry details

Key details

Study ID
NCT02444832
Lead sponsor
Hospital Clinic of Barcelona
Collaborators
Hospitales Universitarios Virgen del Rocío, Hospital Universitario Reina Sofia de Cordoba
Responsible party
Federico Zarco (Neurorradiologist,, Hospital Clinic of Barcelona) — Principal investigator
First posted
May 15, 2015
Start date
May 2015
Primary completion
Jun 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
May 15, 2015

Study contacts

Federico Zarco, MD
Contact
fzarco@clinic.ub.es
932275400 ext. 2662
Federico Zarco, MD
principal investigator · Hospital Clinic of Barcelona

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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