ISRCTN ISRCTN82461286
DOI https://doi.org/10.1186/ISRCTN82461286
Secondary identifying numbers 05/Q1604/23
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

Study website

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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesTo 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) studiedIntracranial aneurysms
Intervention1. 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 typeOther
Primary outcome measureRate 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 outcome measures1. 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
Overall study start date15/09/2005
Completion date15/09/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants500
Key inclusion criteria1. 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 criteria1. 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 enrolment15/09/2005
Date of final enrolment15/09/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Oxford Neurovascular & Neuroradiology Research Unit (ONNRU)
Oxford
OX3 9DU
United Kingdom

Sponsor information

Micrus Endovascular Ltd. (UK)
Industry

Unit 4
First Floor
Stansted Courtyard
Parsonage Lane
Takeley
Bishop's Stortford
CM22 6PU
United Kingdom

Phone +44 (0)1279 873150
Email mellis@micruscorp.com
Website http://www.micrusendovascular.com

Funders

Funder type

Industry

Micrus Endovascular Corporation (USA) (ref: RD/308/1)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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