Cerecyte coil trial

ISRCTN	ISRCTN82461286
DOI	https://doi.org/10.1186/ISRCTN82461286
Protocol serial number	05/Q1604/23
Sponsor	Micrus Endovascular Ltd. (UK)
Funder	Micrus Endovascular Corporation (USA) (ref: RD/308/1)

Submission date: 09/09/2005
Registration date: 26/10/2005
Last edited: 15/09/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Andrew Molyneux
Scientific

Oxford Neurovascular & Neuroradiology Research Unit (ONNRU)
West Wing, Level 6
John Radcliffe Hospital Headley Way
Oxford
OX3 9DU
United Kingdom

Phone	+44 (0)1865 234753
Email	andy.molyneux@nds.ox.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To demonstrate that the rate of angiographic occlusion in the treatment of intracranial aneurysms is superior for patients treated with Cerecyte coils than for patients treated with standard bare platinum coils.
Ethics approval(s)	Multicentre Research Ethics Committee (MREC), Oxfordshire REC A 18/052005; substantial amendment approved on 24/04/2006, ref: 05/Q1604/23
Health condition(s) or problem(s) studied	Intracranial aneurysms
Intervention	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 months 3. The patient will also have MRI angiography at 1 year Amendments to interventions as of 30/05/2006: 1. Diagnostic three-dimensional computed tomographic angiography (3D CTA) or angiogram 2. Endovascular coil treatment 3. Follow-up angiography at 6 months (range 5-7 months) after treatment 4. MRI angiography between 12 and 24 months after treatment if deemed necessary and in line with normal practice at the recruiting centre
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	15/09/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	500
Key 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
Key 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
Date of first enrolment	15/09/2005
Date of final enrolment	15/09/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Oxford Neurovascular & Neuroradiology Research Unit (ONNRU)

Oxford
OX3 9DU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	clinical results	01/03/2012		Yes	No
Results article	angiographic results	01/10/2012		Yes	No
Results article	results	01/01/2014		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes