NCT03852680

Brief 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.

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

February 10, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

May 11, 2020

Status Verified

May 1, 2020

Enrollment Period

1.4 years

First QC Date

February 10, 2019

Last Update Submit

May 7, 2020

Conditions

Brain Aneurysm

Keywords

wide necked intracranial aneurysms

Outcome Measures

Primary Outcomes (2)

  • 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.

    one day before treatment, within 3 days after treatment.

  • 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)

    within 3 days after treatment and after 6 months

Secondary Outcomes (3)

  • incidence of aneurysm rupture

    during operation or within 7 days after treatment

  • incidence of cerebral vasospasm

    within 30 days after treatment

  • Mortality rate

    within 30 days after treatment

Interventions

aneurysm clippingPROCEDURE

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

Also known as: aneurysm coiling, flow diversion

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine

Asyut, 71515, Egypt

Location

Related Publications (9)

  • 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.

    PMID: 24646873BACKGROUND

  • 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.

    PMID: 17332442BACKGROUND

  • 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.

    PMID: 12063434BACKGROUND

  • 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.

    PMID: 17569982BACKGROUND

  • 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.

    PMID: 20678369BACKGROUND

  • 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.

    PMID: 9672035BACKGROUND

  • 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.

    PMID: 16944050BACKGROUND

  • 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.

    PMID: 24641489BACKGROUND

  • 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.

    PMID: 23321438BACKGROUND

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Study Officials

  • Ahmed Ahmed Abokresha, Assisstant professor

    Assiut University

    STUDY DIRECTOR

  • Mohamed El-Sayed Mahmoud, Assisstant professor

    Assiut University

    STUDY DIRECTOR

  • Abd El-hai Moussa Abd El-Latif, professor of neurosurgery

    Assiut University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant lecturer of neurosurgery

Study Record Dates

First Submitted

February 10, 2019

First Posted

February 25, 2019

Study Start

March 1, 2019

Primary Completion

August 1, 2020

Study Completion

March 30, 2021

Last Updated

May 11, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)