Multicenter Retrospective Registry of Anterior Communicating Artery Aneurysms With Endovascular Therapy

Intracranial Aneurysm Clinical Trial

— MACAARET  

Official title:

Multicenter Retrospective Registry of Anterior Communicating Artery Aneurysms With Endovascular Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02444832
• Other study ID #: NeurovascCDI001
• Status: Recruiting
• Phase: N/A
• First received: May 12, 2015
• Last updated: May 14, 2015
• Start date: May 2015
• Est. completion date: December 2017

Study information

• Verified date: May 2015
• Source: Hospital Clinic of Barcelona
• Contact: Federico Zarco, MD
• Phone: 932275400
• Email: fzarco[@]clinic.ub.es
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Hospital Universitario Reina Sofia, Hospitales Universitarios Virgen del Rocío

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective Aneurysm Coiling (no residual cerebral aneurysm)		1 year	Yes
Secondary	All Cause Mortality		1 year	Yes
Secondary	Neurological Outcome (classified with the Glasgow Outcome Scale, Rankin Scale)	All patients will be classified with the Glasgow Outcome Scale, Rankin Scale.	1 year	Yes
Secondary	Procedural device-related serious adverse events		1 year	Yes