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AzTrials

Brain AneurysmNCT03852680

Current Treatment Modalities for Wide Necked Intracranial Aneurysms

A study testing aneurysm clipping in people with Brain Aneurysm, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Give an effective treatment for intracranial wide necked aneurysm and can detect the best method could be used. Improve the outcome of these patients and decease rate of recurrence and complications. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Brain Aneurysm
What is being tested?
aneurysm clipping
Type of treatment
Surgery or procedure
How many people
40 participants
Where
1 siteEgypt
Study dates
1 Mar 2019to 30 Mar 2021
Phase
Interventional
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Patients who undergo surgical clipping or any endovascular techniques used in treatment of wide-necked intracranial aneurysms. Wide-necked aneurysms are defined as aneurysms with a fundus-to-neck ratio of less than 2 or a neck diameter of 14 mm.

Who cannot join

  • patients with narrow-necked intracranial aneurysms
  • patients who are unfit for any neurosurgical interventions.
  • patients who had artery aneurysm and vascular malformation due to some trauma.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Faculty of medicine

    Asyut, 71515

Other trials in Egypt

About this study

  • Give an effective treatment for intracranial wide necked aneurysm and can detect the best method could be used.
  • Improve the outcome of these patients and decease rate of recurrence and complications.
Read the detailed description

The prevalence of intracranial aneurysms in the adult population is estimated to be around 2 %. Most remain asymptomatic, but there is a risk of rupture of 1.2 % per year, and this risk increases in line with the diameter of the aneurysm. If rupture occurs, subarachnoid hemorrhage and its associated acute complications are responsible for high mortality (between 30 and 67 %) and morbidity (between 15 and 30 %).

Coil embolization of intracranial aneurysms has made remarkable technological progress since the International Subarachnoid Aneurysm Trial (ISAT) data were released in 2005. However, wide-necked aneurysms remain a great challenge to be treated via the endovascular means, as they are associated with a significantly greater incidence of adverse events when compared with narrow-necked ones.

Acutely ruptured wide-necked intracranial aneurysms pose technical challenges to the treating physician; thus, multiple endovascular techniques have been described to treat these lesions, including balloon-assisted coil placement, double microcatheter technique, and microcatheter assisted coil placement. However, the use of these techniques can sometimes be limited, owing to the lack of permanent support for the coil mass inside the aneurysm sac, which may lead to coil prolapse or migration after the procedure, especially for wide-necked aneurysms (dome-to-neck ratio is less than 1) or tiny aneurysms (3 mm). Therefore, surgical clipping is preferred for acutely ruptured wide-necked intracranial aneurysms in most institutions. Surgery, however, may also be challenging in some of these lesions, since clips may slip, and surgical access may be limited because of the swelling of the brain in the acute setting of a subarachnoid hemorrhage.

Flow diverters are new implantable medical devices that make possible to embolize wide-necked aneurysms without the use of coils; the efficacy results published to date are encouraging in terms of complete occlusion in the medium-term, thereby confirming the innovative nature of the flow diversion technique that we aim to evaluate without the use of coils.

Conditions
Brain Aneurysm
Being tested
aneurysm clipping
Keywords
wide necked intracranial aneurysms
Medical subject headings
Intracranial Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • aneurysm clippingProcedure or surgery

    Also called aneurysm coiling, flow diversion

    treatment of wide necked intracranial aneurysms using different modalities as open surgery by clipping or endovascular techniques as coiling and flow diversion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Independent clinical outcome changes

    The changes in clinical condition of the patients will be assessed before and after treatment using modified Rankin scale, as the scale runs from 0-6, running from perfect health without symptoms to death.

    0 - No symptoms.

    1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
    2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    3. - Moderate disability. Requires some help, but able to walk unassisted.
    4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    6. - Dead.

    Measured: one day before treatment, within 3 days after treatment.

  2. Postoperative angiographic occlusion rate changes

    The changes in postoperative angiographic occlusion rate will be assessed in different time frame using CT angiography or conventional angiography (if CT angiography is not conclusive)

    Measured: within 3 days after treatment and after 6 months

Secondary outcomes (3)

  1. incidence of aneurysm rupture

    as complication of treatment

    Measured: during operation or within 7 days after treatment

  2. incidence of cerebral vasospasm

    as complication of treatment

    Measured: within 30 days after treatment

  3. Mortality rate

    as a result of treatment

    Measured: within 30 days after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2019
  2. Study start1 Mar 2019
  3. Primary completion1 Aug 2020 (estimated)
  4. Study completion30 Mar 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03852680
Sponsor's protocol ID
Intracranial aneurysms
Status last verified
May 2020
First submitted
10 Feb 2019
Last updated
11 May 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Brown RD Jr, Broderick JP. Unruptured intracranial aneurysms: epidemiology, natural history, management options, and familial screening. Lancet Neurol. 2014 Apr;13(4):393-404. doi: 10.1016/S1474-4422(14)70015-8.

    PubMed 24646873

  • Wermer MJ, van der Schaaf IC, Algra A, Rinkel GJ. Risk of rupture of unruptured intracranial aneurysms in relation to patient and aneurysm characteristics: an updated meta-analysis. Stroke. 2007 Apr;38(4):1404-10. doi: 10.1161/01.STR.0000260955.51401.cd. Epub 2007 Mar 1.

    PubMed 17332442

  • Matillon Y. [Ruptured intracranial aneurysms: Occlusion by endovascular approach versus exclusion by microsurgery]. J Radiol. 2002 May;83(5):662-4. No abstract available. French.

    PubMed 12063434

  • Layton KF, Cloft HJ, Gray LA, Lewis DA, Kallmes DF. Balloon-assisted coiling of intracranial aneurysms: evaluation of local thrombus formation and symptomatic thromboembolic complications. AJNR Am J Neuroradiol. 2007 Jun-Jul;28(6):1172-5. doi: 10.3174/ajnr.A0490.

    PubMed 17569982

  • Moret J, Cognard C, Weill A, Castaings L, Rey A. The "Remodelling Technique" in the Treatment of Wide Neck Intracranial Aneurysms. Angiographic Results and Clinical Follow-up in 56 Cases. Interv Neuroradiol. 1997 Mar 30;3(1):21-35. doi: 10.1177/159101999700300103. Epub 2001 May 15.

    PubMed 20678369

  • Baxter BW, Rosso D, Lownie SP. Double microcatheter technique for detachable coil treatment of large, wide-necked intracranial aneurysms. AJNR Am J Neuroradiol. 1998 Jun-Jul;19(6):1176-8.

    PubMed 9672035

  • Ihn YK, Kim DI, Kim BS, Lee JM. Utility of catheter-assisted Guglielmi detachable coiling in the treatment of wide-necked aneurysms. Acta Neurochir (Wien). 2006 Oct;148(10):1045-52; discussion 1052. doi: 10.1007/s00701-006-0881-7. Epub 2006 Sep 8.

    PubMed 16944050

  • Gory B, Sigovan M, Vallecilla C, Courbebaisse G, Turjman F. High-resolution MRI visualization of aneurysmal thrombosis after flow diverter stent placement. J Neuroimaging. 2015 Mar-Apr;25(2):310-311. doi: 10.1111/jon.12110. Epub 2014 Mar 19.

    PubMed 24641489

  • Brinjikji W, Murad MH, Lanzino G, Cloft HJ, Kallmes DF. Endovascular treatment of intracranial aneurysms with flow diverters: a meta-analysis. Stroke. 2013 Feb;44(2):442-7. doi: 10.1161/STROKEAHA.112.678151. Epub 2013 Jan 15.

    PubMed 23321438

Questions about this trial

What is this clinical trial studying?

A study testing aneurysm clipping in people with Brain Aneurysm, run by Assiut University at 1 site in Egypt.

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 3 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 11 May 2020. 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 Egypt. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Independent clinical outcome changes (time frame: one day before treatment, within 3 days after treatment.). The study lists 2 primary outcomes in all. 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 NCT03852680, which also lists 9 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 11 May 2020.

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