None listed
Conditions
Brief summary
Some brain aneurysms, when they bleed, are difficult or impossible to treat safely with "conventional" techniques. There is a device similar to a stent which has been used for 10 years to repair some aneurysms, called the Pipeline Embolisation Device, which has previously needed aspirin plus a stronger blood thinner before inserting it to prevent the device clotting and causing a stroke. The latest version of this device Pipeline-Shield), in use in Australia for 3 years now, has a coating which mimics the lining of blood vessels. This means that the stronger blood thinner may not be required to keep the device from clotting. We have been using the Pipeline-Shield with aspirin only to treat some patients with these "impossible" aneurysms under compassionate use for 2 years with very promising results. We hypothesise that using the device in this manner with aspirin only is safe, and that the device will clot only very rarely if used in this manner.
Interventions
The intervention will consist of endovascular delivery one or more Pipeline-Shield devices to treat patients with this particular subset of difficult aneurysms using aspirin as the sole antiplatelet agent. This will be done by experienced (CCINR-certified) interventional neuroradiologists. The procedure will be a once-only intervention, with follow up on imaging studies using a combination of MRI and angiography. Clinical follow up will also be obtained. The follow up period for this trial will
The intervention will consist of endovascular delivery one or more Pipeline-Shield devices to treat patients with this particular subset of difficult aneurysms using aspirin as the sole antiplatelet agent. This will be done by experienced (CCINR-certified) interventional neuroradiologists. The procedure will be a once-only intervention, with follow up on imaging studies using a combination of MRI and angiography. Clinical follow up will also be obtained. The follow up period for this trial will be 6 months. Aspirin will be administered as a 500mg intravenous dose during the procedure and continued orally or via nasogastric administration post procedurally, depending on the patients' level of consciousness at a dose of 100-300mg daily in single or divided dose. Compliance will be monitored during the inpatient period by medication charts, and during the outpatient phase by regular follow up phone calls with patients/carers and at gazetted clinical face-to-face meetings.
Sponsors
Dr Jason Wenderoth
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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: o Requirement for immediate ventricular drainage o Requirement for urgent craniotomy and haematoma evacuation o Requirement for tracheostomy or other major surgical procedure o Allergy 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
Outcome results
None listed