Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Andrew Molyneux
ORCID ID
Contact details
Oxford Neurovascular & Neuroradiology Research Unit (ONNRU)
West Wing
Level 6
John Radcliffe Hospital Headley Way
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 234753
andy.molyneux@nds.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
05/Q1604/23
Study information
Scientific title
Acronym
Study hypothesis
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
Multicentre Research Ethics Committee (MREC), Oxfordshire REC A 18/052005; substantial amendment approved on 24/04/2006, ref: 05/Q1604/23
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
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 outcome measures
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
Overall trial start date
15/09/2005
Overall trial end date
15/09/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
500
Participant 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
Recruitment start date
15/09/2005
Recruitment end date
15/09/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Oxford Neurovascular & Neuroradiology Research Unit (ONNRU)
Oxford
OX3 9DU
United Kingdom
Sponsor information
Organisation
Micrus Endovascular Ltd. (UK)
Sponsor details
Unit 4
First Floor
Stansted Courtyard
Parsonage Lane
Takeley
Bishop's Stortford
CM22 6PU
United Kingdom
+44 (0)1279 873150
mellis@micruscorp.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Micrus Endovascular Corporation (USA) (ref: RD/308/1)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 clinical results in http://www.ncbi.nlm.nih.gov/pubmed/22207299
2012 angiographic results in http://www.ncbi.nlm.nih.gov/pubmed/22836352
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/23868159
Publication citations
-
Clinical results
Coley S, Sneade M, Clarke A, Mehta Z, Kallmes D, Cekirge S, Saatci I, Roy D, Molyneux A, Cerecyte coil trial: procedural safety and clinical outcomes in patients with ruptured and unruptured intracranial aneurysms., AJNR Am J Neuroradiol, 2012, 33, 3, 474-480, doi: 10.3174/ajnr.A2836.
-
Angiographic results
Molyneux AJ, Clarke A, Sneade M, Mehta Z, Coley S, Roy D, Kallmes DF, Fox AJ, Cerecyte coil trial: angiographic outcomes of a prospective randomized trial comparing endovascular coiling of cerebral aneurysms with either cerecyte or bare platinum coils., Stroke, 2012, 43, 10, 2544-2550, doi: 10.1161/STROKEAHA.112.657254.
-
Results
Rezek I, Lingineni RK, Sneade M, Molyneux AJ, Fox AJ, Kallmes DF, Differences in the angiographic evaluation of coiled cerebral aneurysms between a core laboratory reader and operators: results of the Cerecyte Coil Trial., AJNR Am J Neuroradiol, 2014, 35, 1, 124-127, doi: 10.3174/ajnr.A3623.