Intracranial aneurysms Circulatory System Subarachnoid haemorrhage
Conditions
Interventions
1. Diagnostic 3D CTA or angiogram
2. Comparing a new approved endovascular coil device (Cerecyte) with existing platinum coil devices to produce occlusion of the aneurysm on follow-up angiography at 6
Sponsors
Micrus Endovascular Ltd. (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged between 18 and 70 with a ruptured or unruptured intracranial aneurysm judged suitable for endovascular treatment by platinum coil occlusion 2. Aneurysm size of less than a 18 mm maximum lumen diameter and a neck width 2 mm or greater. 3D visualisation of neck on computed tomography angiography (CTA) or 3D angiography is desirable. 3. Patients planned for treatment of their aneurysm(s) 4. Patients capable of providing their own written informed consent (i.e. World Federation of Neurosurgical Societies [WFNS] grade 1 & 2) following subarachnoid haemorrhage (SAH) or undergoing treatment for an unruptured intracranial aneurysm (UIA) 5. Patient is willing and likely to return for follow-up angiography at 6 months (range 5-7 months) after treatment 6. Patient is willing to undergo a further imaging study at 12 months after treatment (magnetic resonance imaging [MRI] angiogram) Amendments to inclusion criteria as of 30/05/2006 4. Patients capable of providing their own written informed consent (i.e.World Federation of Neurological Surgeons [WFNS] grade 1 and 2) following subarachnoid haemorrhage (SAH) or Rankin score 1 and 2 for those undergoing treatment for an unruptured intracranial aneurysm (UIA) 6. Patient is willing to undergo a further imaging study between 12 and 24 months after treatment (magnetic resonance imaging [MRI] angiogram or cerebral angiogram) if deemed necessary and possible, in line with normal practice at the recruiting centre
Exclusion criteria
Exclusion criteria: 1. Patients in poor grade after SAH (grade 3, 4 or 5) 2. Large aneurysms greater than 18 mm and giant aneurysms 3. Aneurysm neck narrower than 2 mm 4. Patient in whom stent placement is planned or performed (balloon assistance techniques allowed) 5. Patient is unwilling or unlikely to return for follow-up angiogram 6. Patients in whom that centre regard follow-up intra-arterial angiography not to be indicated 7. Lack of informed consent 8. The patient has undergone prior coil treatment or attempted treatment of the target aneurysm including prior surgical treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of angiographic occlusion of the aneurysm at 6 months to demonstrate if the rate of occlusion is superior for patients treated with Cerecyte coils compared with patients treated with bare platinum coils. Amendments to primary outcome as of 30/05/2006: Rate of angiographic occlusion of the aneurysm at 6 months to demonstrate whether the rate of occlusion is superior for patients treated with Cerecyte coils compared with patients treated with bare platinum coils. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complication rate of treatment using Cerecyte coils compared to the standard bare platinum coils 2. Follow-up angiographic occlusion of the aneurysms treated with Cerecyte coils are more durable at 1 year Amendments to secondary outcome as of 30/05/2006: 1. To observe the rate of procedural complications and adverse events for treatment using Cerecyte coils compared with standard bare platinum coils 2. To observe if retreatment rates are different between the two groups 3. To observe if a healing reaction is seen in a proportion of patients treated with Cerecyte coils and in no patients treated with standard platinum coils 4. Follow-up angiographic occlusion of the aneurysms treated with Cerecyte coils demonstrate that they are more durable at one year | — |
Countries
United Kingdom
Outcome results
None listed