Aneurysm Embolization System (AES) for treatment of intracranial aneurysms

Not Applicable

Completed

• Conditions: Intracranial aneurysms; Circulatory System; Cerebral aneurysm, nonruptured

• Registration Number: ISRCTN72343080
• Lead Sponsor: Covidien LP (USA)

Brief Summary

2018 results in https://pubmed.ncbi.nlm.nih.gov/29669856/ (added 17/08/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-10
• Study Completion: 2016-12-01
• Last Update Posted: 31 August 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 63

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)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Safety variables look at occurrence and frequency of:<br> 1. Adverse Events (AEs)<br> 2. Adverse Device Effects (ADEs)<br> 3. Serious Adverse Events (SAEs)<br> 4. Unanticipated Adverse Device Effects (UADEs)<br><br> Efficacy variables relate to the ability of the device to embolize the aneurysm at select time points<br>

Secondary Outcome Measures

Name	Time	Method
Performance variable evaluate the system?s use in helping to get the device to aneurysm