Cerecyte coil trial

Completed

• Conditions: Intracranial aneurysms; Circulatory System; Subarachnoid haemorrhage

• Registration Number: ISRCTN82461286
• Lead Sponsor: Micrus Endovascular Ltd. (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-26
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 500

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified