Aneurysm Embolization System (AES) for treatment of intracranial aneurysms
| ISRCTN | ISRCTN72343080 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72343080 |
| Secondary identifying numbers | PMCF AES001 |
- Submission date
- 09/06/2011
- Registration date
- 10/06/2011
- Last edited
- 17/08/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
An intracranial aneurysm is a bulge in a blood vessel inside the brain, caused by a weakness in the vessel wall. There are three main treatment options available: observation/medical management, endovascular treatment, and surgical treatment. Although many aneurysms are treated surgically, an increasing number are treated by an endovascular approach, due to the invasive nature of the surgery and its increased risk of complications. In endovascular procedures, a catheter (small tube) is guided through the blood vessels to the location of the aneurysm and soft platinum coils are deployed into the aneurysm to trigger the formation of a blood clot, sealing off the aneurysm. However, the effectiveness of coiling is not as high as surgical clipping (where the aneurysm is sealed shut using a tiny metal clip), as there is an increased need to repeat the treatment. Despite this, endovascular treatment has been proven to improve patient outcomes. The LUNA™ AES provides an alternative to coiling, with the benefits of endovascular treatment but with improved wound healing at the aneurysm and thus a more durable blockage of the aneurysm. The aim of this study is to assess the safety, performance and effectiveness of the LUNA™ AES for the treatment of intracranial aneurysms.
Who can participate?
Patients aged 18 to 75 with an intracranial aneurysm
What does the study involve?
The LUNA™ AES is a small device that is delivered into the aneurysm through a small delivery tube. The device fills the aneurysm with the goal to reduce the risk of the aneurysm bursting and/or bleeding in the future while still maintaining good blood flow to the other blood vessels in the brain. The participant is monitored at various times during the study follow up (up to 36 months). A variety of tests are performed including one or more of the following: physical examination (including medical history), neurological (brain) tests, angiogram (a type of x-ray used to examine blood vessels).
What are the possible benefits and risks of participating?
Potential complications include but are not limited to the following: pain, infection, bleeding, adverse tissue reaction, blood vessel damage, stroke, aneurysm recurrence, unintended movement of the implant, unintended blood clot, and death
Where is the study run from?
Hopital de la Fondation Rothschild (France)
When is the study starting and how long is it expected to run for?
June 2011 to December 2016
Who is funding the study?
Covidien LP (USA)
Who is the main contact?
Dr Michel Piotin
Contact information
Scientific
Hopital de la Fondation Rothschild
Chef du Service de Neuroradiologie Interventionnelle (Department of Interventional Radiology)
25-29 rue Manin 75940
Paris
CEDEX 19
France
Study information
| Study design | Prospective multi-centre non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Aneurysm Embolization System (AES) for treatment of intracranial aneurysms: a post-market clinical follow-up |
| Study acronym | AES |
| Study objectives | The primary objectives of this study are to characterize the safety, performance and efficacy of the LUNA™ AES for the treatment of intracranial aneurysms. |
| Ethics approval(s) | Committee to Protect People Ile de France XI (Comité de Protection des Personnes Ile de France XI), 03/05/2011 |
| Health condition(s) or problem(s) studied | Intracranial aneurysms |
| Intervention | Current interventions as of 24/04/2014: The LUNA™ AES is a small device that is delivered into the aneurysm through a small delivery tube. The device fills the aneurysm with the goal to reduce the risk of the aneurysm bursting and/or bleeding in the future while still maintaining good blood flow to the other blood vessels in the brain. The procedure is similar to an angiogram. Using a guiding catheter and imaging, the LUNA™ AES device is placed into the appropriate location. At baseline and following the procedure, the participant is monitored at various times during the study follow up (up to 36 months). A variation of tests are performed and include one or more of the following: medical history collected, physical exam, pregnancy test (if applicable), neurological tests, angiogram and a modified rankin scale. Previous interventions: The LUNA™ AES is a small device that is delivered into the aneurysm through a small delivery tube. The device fills the aneurysm with the goal to reduce the risk of the aneurysm bursting and/or bleeding in the future while still maintaining good blood flow to the other blood vessels in the brain. The procedure is similar to an angiogram. Using a guiding catheter and imaging, the LUNA™ AES device is placed into the appropriate location. At baseline and following the procedure, the participant is monitored at various times during the study follow up (up to 12 months). A variation of tests are performed and include one or more of the following: medical history collected, physical exam, pregnancy test (if applicable), neurological tests, angiogram and a modified Rankin scale. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Safety variables look at occurrence and frequency of: 1. Adverse Events (AEs) 2. Adverse Device Effects (ADEs) 3. Serious Adverse Events (SAEs) 4. Unanticipated Adverse Device Effects (UADEs) Efficacy variables relate to the ability of the device to embolize the aneurysm at select time points |
| Secondary outcome measures | Performance variable evaluate the systems use in helping to get the device to aneurysm |
| Overall study start date | 14/06/2011 |
| Completion date | 01/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 63 |
| Total final enrolment | 63 |
| Key inclusion criteria | 1. Sex: male or female 2. Age: 18 to 75 years 3. Subject must be able to understand and be willing to sign an consent form 4. Subject must be considered a candidate for aneurysm coiling 5. Subject must be willing and able to participate in all aspects of the study and agree to comply with all study requirements for the duration of the study. This includes availability of reliable transportation and sufficient time to attend all follow-up visits 6. Subject is diagnosed with an intracranial aneurysm that has never been previously treated 7. The location, shape, neck size, overall aneurysm geometry and size must be consistent with the parameters set forth in the Instructions for Use ( IFU) for the LUNA™ AES in order to be acceptable for treatment 8. Subject must be of sufficient and stable medical health, as evaluated by the Prinicipal Investigator (PI) |
| Key exclusion criteria | 1. Subject has a fusiform aneurysm 2. The target aneurysm has been previously treated by surgical or endovascular means 3. Subject has symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease 4. Subject has pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer 5. Subject has renal and/or hepatic insufficiency 6. Subject has systemic infection in the body at the time of the LUNA™ AES procedure 7. Subject has history of neurovascular or neurologic disease that in the opinion of the Investigator would make them a poor candidate for the LUNA™ AES procedure 8. Subject is contraindicated for radiographic contrast media 9. Subject has severe coagulopathy (prothrombin time > 3 seconds over control or platelet count < 100,000) or is presently taking heparin, Coumadin® (warfarin), or other anticoagulants or other medications which impede coagulation or platelet aggregation 10. Subject has collagen vascular disease 11. Subject is undergoing chronic steroid therapy 12. Subject is undergoing immunosuppressive therapy 13. Subject has relative contraindication to angiography (e.g., serum creatinine level > 2.5 mg/dL) 14. Female subject who is pregnant (i.e., has a positive urine or blood pregnancy test prior to device implant), is suspected to be pregnant, is lactating or is of childbearing potential but refuses to use adequate contraception during the study 15. Subjects who have poorly controlled psychiatric disease including but not limited to manic-depressive disorder, schizophrenia, borderline personality disorder, depression or suicidal tendencies 16. Subject currently uses or has a history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than 4 alcoholic drinks per day) 17. Subject has participated in a clinical study with an investigational new drug, biological, or therapeutic device within 28 days prior to enrollment in this study, and does not agree to abstain from participation in other clinical trials of any kind during this study 18. The subject is unable to comply with trial procedures or protocol 19. Any co-morbid disease or condition expected to compromise survival or ability to complete follow-up assessments to 6 months |
| Date of first enrolment | 14/06/2011 |
| Date of final enrolment | 24/04/2014 |
Locations
Countries of recruitment
- Belgium
- France
- Germany
- Italy
- Poland
- Sweden
Study participating centre
CEDEX 19
France
Sponsor information
Industry
c/o Dr Nagesh Uppuluri
9775 Toledo Way
Irvine
92618
United States of America
| Nagesh.Uppuluri@covidien.com | |
| Website | http://www.covidien.com/ |
"ROR" |
https://ror.org/00grd1h17 |
Funders
Funder type
Industry
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 | 01/12/2018 | 17/08/2020 | Yes | No |
Editorial Notes
17/08/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
22/06/2016: Plain English summary added.
24/04/2014: the following changes were made to the trial record:
1. The sponsor/funder was changed from Nfocus Neuromedical, Inc (USA) to Covidien LP (USA).
2. The overall trial end date was changed from 31/12/2013 to 01/12/2016.
04/02/2013: the following changes were made to the trial record:
1. Belgium, Germany, Italy, Poland and Sweden were added to the countries of recruitment.
2. The overall trial end date was changed from 14/08/2012 to 31/12/2013.
