Hydrocoil: Endovascular Aneurysm Occlusion and Packing Study
| ISRCTN | ISRCTN30531382 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30531382 |
| Secondary identifying numbers | N/A |
- Submission date
- 31/07/2004
- Registration date
- 01/04/2005
- Last edited
- 14/11/2013
- 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
Not provided at time of registration
Contact information
Dr Philip White
Scientific
Scientific
Dept. of Neuroradiology
Western General Hospital
Crewe Road
Edinburgh
EH4 2XU
United Kingdom
| pmw@skull.dcn.ed.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information sheet can be found at http://www.mymainplace.com/HelpStudy/Collateral/PIS%20V3.doc. |
| Scientific title | |
| Study acronym | HELPS |
| Study hypothesis | The HELPS (hydrocoil: endovascular aneurysm occlusion and packing study) trial aims to compare major aneurysm recurrence rate on follow-up angiography at 15 - 18 months between patients allocated hydrocoil versus patients allocated bare platinum coiling. |
| Ethics approval(s) | Not provided at time of registration. |
| Condition | Intracranial aneurysms |
| Intervention | This study is now closed to recruitment. Patients are randomised to the hydrogel coil or control arms by using concealed allocation with minimisation matching groups. Any bare platinum coils are allowed in the control arm, and assist devices could be used as clinically required. |
| Intervention type | Other |
| Primary outcome measure | Angiographic outcomes at 15-18 months between aneurysms coiled using bare platinum coils (control group) and those coiled using hydrocoil embolic system. |
| Secondary outcome measures | Secondary outcome measures include packing density, clinical outcome, rebleed and retreatment comparisons between these 2 groups. |
| Overall study start date | 01/09/2004 |
| Overall study end date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 500 |
| Participant inclusion criteria | Patient presenting with a cerebral aneurysm deemed to require endovascular treatment by the neurosurgeon/neurointerventionist (generically referred to subsequently as 'the neurovascular team'), and: 1. Patient has given fully informed consent to endovascular coiling procedure 2. Aneurysm 2 - 25 mm in maximum diameter 3. Anatomy such that endovascular occlusion is deemed possible (not necessarily probable) 4. The neurointerventionist is content to use either bare platinum or hydrocoil embolic system (HES) depending on randomisation result (i.e., clinical equipoise principle applies) 5. The neurointerventionist is content not to use any other type of coated coil 6. Patient World Federation of Neurological Surgeons (WFNS) Grade 0 - 2 and aged 18 - 75 years 7. The patient has not been previously randomised into this trial 8. Aneurysm has not previously been treated (by coiling or clipping) |
| Participant exclusion criteria | Subjects will not be considered for the trial unless they meet all the inclusion criteria. If the patient has more than one aneurysm requiring treatment at the same treatment episode they will not be eligible for the trial. If treatment will be staged in a patient with multiple aneurysms and only one aneurysm will be treated at one sitting then the patient is eligible. However, a patient may not be randomised into the study more than once. From the moment of randomisation, the patient is in the trial whether they receive trial treatment or not, and will be followed up and accounted for in the final analysis (intention-to-treat). Death or procedural/disease related morbidity may result in some subjects not having check angiography (or magnetic resonance angiography [MRA] if unit uses this as standard mode of follow-up). These patients will be counted as poor outcomes in the primary analysis. Retreatment of previously coiled or clipped aneurysm is an exclusion criteria. Use of coil assist devices (stent, balloon, trispan etc.) should be recorded but is not an exclusion criteria. It must be recorded in order to ascertain if any difference in use between control and hydrocoil groups acts as a potential confounding variable. |
| Recruitment start date | 01/09/2004 |
| Recruitment end date | 30/06/2008 |
Locations
Countries of recruitment
- Argentina
- Australia
- Brazil
- France
- Germany
- Scotland
- United Kingdom
- United States of America
Study participating centre
Dept. of Neuroradiology
Edinburgh
EH4 2XU
United Kingdom
EH4 2XU
United Kingdom
Sponsor information
Lothian University Hospitals Division (UK)
Hospital/treatment centre
Hospital/treatment centre
Research & Development Office, Room G8137
Royal Infirmary of Edinburgh
Little France Crescent
Edinburgh
EH16 4SA
Scotland
United Kingdom
| neil.feltham@luht.scot.nhs.uk | |
| Website | http://www.research.luht.scot.nhs.uk/ |
"ROR" |
https://ror.org/03q82t418 |
Funders
Funder type
Industry
Microvention Incorporated (USA)
No information available
Lothian University Hospitals Division (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2008 | Yes | No | |
| Results article | results | 14/05/2011 | Yes | No |
