Intracranial AneurysmMACAARETNCT02444832
Multicenter Retrospective Registry of Anterior Communicating Artery Aneurysms With Endovascular Therapy
An observational study of Intracranial Aneurysm and Anterior Communicating Artery Aneurysm, run by Hospital Clinic of Barcelona at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Aneurysm, Anterior Communicating Artery Aneurysm, Cerebral Aneurysm
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- May 2015to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Communicating Artery Aneurysm treated with endovascular coiling.
Who may be able to join
- Patient with Anterior Communicating Artery Aneurysm treated with endovascular coiling.
Who cannot join
- Patients without imaging follow up of at least 12 months after endovascular treatment.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic
Barcelona, Barcelona, 08036
Federico Zarco, MD, 932 27 54 00 ext. 2662, fzarco@clinic.ub.es
Federico
About this study
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.
Read more
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
- Conditions
- Intracranial Aneurysm, Anterior Communicating Artery Aneurysm, Cerebral Aneurysm, Aneurysm, Ruptured
- Medical subject headings
- Intracranial Aneurysm, Aneurysm, Ruptured
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective Aneurysm Coiling (no residual cerebral aneurysm)
Measured: 1 year
Secondary outcomes (3)
All Cause Mortality
Measured: 1 year
Neurological Outcome (classified with the Glasgow Outcome Scale, Rankin Scale)
All patients will be classified with the Glasgow Outcome Scale, Rankin Scale.
Measured: 1 year
Procedural device-related serious adverse events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Hospitales Universitarios Virgen del Rocío, Hospital Universitario Reina Sofia de Cordoba
- Responsible party
- Principal investigator, Federico Zarco, Hospital Clinic of Barcelona
- Investigators
- Federico Zarco, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444832
- Sponsor's protocol ID
- NeurovascCDI001
- Acronym
- MACAARET
- Status last verified
- May 2015
- First submitted
- 12 May 2015
- Last updated
- 15 May 2015
- Results posted
- No
- Data monitoring committee
- No
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 14565533Moret 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 8957810Birknes 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 16823299Molyneux 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
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Retrospective Registry of Anterior Communicating Artery Aneurysms With Endovascular Therapy
- ClinicalTrials.gov ID
- NCT02444832
- Acronym / sponsor ID
- MACAARET / NeurovascCDI001
- Conditions
- Intracranial Aneurysm, Anterior Communicating Artery Aneurysm, Cerebral Aneurysm, Aneurysm, Ruptured
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Hospitales Universitarios Virgen del Rocío, Hospital Universitario Reina Sofia de Cordoba
- Study start
- May 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 15 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Communicating Artery Aneurysm treated with endovascular coiling.
Key inclusion criteria (1 listed)
- Patient with Anterior Communicating Artery Aneurysm treated with endovascular coiling.
Key exclusion criteria (1 listed)
- Patients without imaging follow up of at least 12 months after endovascular treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effective Aneurysm Coiling (no residual cerebral aneurysm)
Time frame: 1 year
3 secondary outcomes
All Cause Mortality
Time frame: 1 year
Neurological Outcome (classified with the Glasgow Outcome Scale, Rankin Scale)
Time frame: 1 year
Procedural device-related serious adverse events
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
- Background: PubMed 14565533Elias 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.
- Background: PubMed 8957810Moret 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.
- Background: PubMed 16823299Birknes 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.
- Background: PubMed 16139655Molyneux 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Federico Zarco, MD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm and Anterior Communicating Artery Aneurysm, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Federico Zarco, MD (932275400 ext. 2662, fzarco@clinic.ub.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective Aneurysm Coiling (no residual cerebral aneurysm) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02444832, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2015.