Current Treatment Modalities for Wide Necked Intracranial Aneurysms

Not Applicable

• Conditions: Brain Aneurysm

• Registration Number: NCT03852680
• Lead Sponsor: Assiut University

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.

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.

Study Timeline

• Study First Submitted: 2019-02-10
• Study First Submitted QC: 2019-02-21
• Study First Posted: 2019-02-25
• Study Start: 2019-03-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-07
• Last Update Posted: 2020-05-11
• Primary Completion: 2020-08-01
• Study Completion: 2021-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Independent clinical outcome changes	one day before treatment, within 3 days after treatment.	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.
Postoperative angiographic occlusion rate changes	within 3 days after treatment and after 6 months	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)

Secondary Outcome Measures

Name	Time	Method
Mortality rate	within 30 days after treatment	as a result of treatment
incidence of cerebral vasospasm	within 30 days after treatment	as complication of treatment
incidence of aneurysm rupture	during operation or within 7 days after treatment	as complication of treatment

Trial Locations

Locations (1)

Faculty of medicine; 🇪🇬 Assuit, Egypt