Repair of Ruptured Brain Aneurysms with a Novel Stent Device and Oral Aspiri

Not Applicable

• Conditions: Ruptured intracranial aneurysm; Stroke - Haemorrhagic

• Registration Number: ACTRN12618001703291
• Lead Sponsor: Dr Jason Wenderoth

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-16
• Last Update Posted: 30 September 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

•18 years or older
•Ruptured intradural aneurysm with morphology not amenable to conventional open or
endovascular repair
•Ruptured intracranial aneurysm unsuitable for open repair, requiring stent support for
endovascular therapy (EVT), but with contraindication to dual antiplatelet therapy, for
example:
oRequirement for immediate ventricular drainage
oRequirement for urgent craniotomy and haematoma evacuation
oRequirement for tracheostomy or other major surgical procedure
oAllergy to clopidogrel, prasugrel
•Criteria above to be evaluated by consultation between the duty open and endovascular
consultants at the participating centre.
•Verbal and written consent from patient and/or next of kin

Exclusion Criteria

•All ruptured aneurysms where conventional open neurosurgical and endovascular repair
techniques are deemed feasible by the open and endovascular consultant on duty
•Inability to obtain consent from patient or guardian/next of kin
•Contraindication or allergy to aspirin
Age <18 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stent patency (short term)<br><br>This will be assessed between days 5-15 with digital subtraction angiography.[5-15 days post treatment.<br><br>This timepoint varies from patient to patient and will only be assessed at a single timepoint within these days unless further angiography is required on clinical grounds.]