Condition category
Circulatory System
Date applied
09/06/2011
Date assigned
10/06/2011
Last edited
22/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michel Piotin

ORCID ID

Contact details

Hopital de la Fondation Rothschild
Chef du Service de Neuroradiologie Interventionnelle (Department of Interventional Radiology)
25-29 rue Manin 75940
Paris
CEDEX 19
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PMCF AES001

Study information

Scientific title

Aneurysm Embolization System (AES) for treatment of intracranial aneurysms: a post-market clinical follow-up

Acronym

AES

Study hypothesis

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

Committee to Protect People Ile de France XI (Comité de Protection des Personnes Ile de France XI), 03/05/2011

Study design

Prospective multi-centre non-randomized study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 system’s use in helping to get the device to aneurysm

Overall trial start date

14/06/2011

Overall trial end date

01/12/2016

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

63

Participant 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

Recruitment start date

14/06/2011

Recruitment end date

24/04/2014

Locations

Countries of recruitment

Belgium, France, Germany, Italy, Poland, Sweden

Trial participating centre

Hopital de la Fondation Rothschild
Paris
CEDEX 19
France

Sponsor information

Organisation

Covidien LP (USA)

Sponsor details

c/o Dr Nagesh Uppuluri
9775 Toledo Way
Irvine
92618
United States of America
-
Nagesh.Uppuluri@covidien.com

Sponsor type

Industry

Website

http://www.covidien.com/

Funders

Funder type

Industry

Funder name

Covidien LP (USA)

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

Publication citations

Additional files

Editorial Notes

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.