Condition category
Circulatory System
Date applied
09/09/2005
Date assigned
26/10/2005
Last edited
15/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.cerecytecoiltrial.com

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 measures

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

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

http://www.micrusendovascular.com

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes