Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000439842
Ethics application status
Approved
Date submitted
10/04/2012
Date registered
18/04/2012
Date last updated
19/04/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
An Observational Study of Basilar Apex Brain Aneurysms Treated With WEB Aneurysm Embolization System
Scientific title
An observational study to assess the progress of basilar apex aneurysms after treatment with the WEB Aneurysm Embolization System
Secondary ID [1] 280224 0
Nil
Universal Trial Number (UTN)
Trial acronym
WEBCAST-B
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intracranial wide-neck basilar apex aneurysms 286171 0
Condition category
Condition code
Neurological 286366 286366 0 0
Other neurological disorders
Cardiovascular 286556 286556 0 0
Hypertension

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
An observational post-market, open label, multicenter study designed to assess the clinical utility of the WEB Aneurysm Embolization System in the treatment of basilar apex aneurysms. The study is longitudinal and will follow study participants for at least a year after treatment.
Intervention code [1] 284555 0
Not applicable
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286822 0
Stasis and chronic occlusion of aneurysm after treatment with WEB Aneurysm Embolization System. Outcome will be evaluated by an independent core lab using a three-point classification system in addition to other occlusion assessment methods.
Timepoint [1] 286822 0
6-month post procedure and for at least 12 months after the initial embolization procedure. All follow-ups will be conducted per institutional standard of care.
Secondary outcome [1] 296734 0
Nil
Timepoint [1] 296734 0
Nil

Eligibility
Key inclusion criteria
- Saccular basilar apex (BA) aneuryms
- Diameter and width of the aneurysm is appropriate size for treatment with the WEB Aneurysm
- Embolization System per device Instructions for Use
- Aneurysm neck size >= 4mm
- Dome-to-Neck (DN) ratio >= 1.0
- Sign and date EC-approved written informed consent prior to initiation of study
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Must not have clinical or angiographic evidence of vasospasm
- Must not have lesion with characteristics unsuitable for endovascular treatment
- Must not have neurologic or psychiatric conditions, which preclude ability to comply with al aspects of the screening, evaluation, treatment, and the post-procedure fol ow-up schedule Must not be concurrently involved in another investigational or post-market study
- Must not have received any investigational device for treatment of the target intracranial aneurysm prior to entry into this trial

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/12/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 4223 0
Hungary
State/province [1] 4223 0
Budapest

Funding & Sponsors
Funding source category [1] 284981 0
Commercial sector/Industry
Name [1] 284981 0
Sequent Medical, Inc.
Country [1] 284981 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Sequent Medical, Inc.
Address
11A Columbia
Aliso Viejo, CA 92656
Country
United States of America
Secondary sponsor category [1] 283845 0
None
Name [1] 283845 0
Address [1] 283845 0
Country [1] 283845 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287064 0
Medical Research Council Scientific and Research Ethics Committee
Ethics committee address [1] 287064 0
Budapest H-1051 Arany Jnos u. 6-8.
Ethics committee country [1] 287064 0
Hungary
Date submitted for ethics approval [1] 287064 0
Approval date [1] 287064 0
25/10/2011
Ethics approval number [1] 287064 0
745/PI/11

Summary
Brief summary
An observational post-market, open label, multicenter study designed to assess the clinical utility of the WEB Aneurysm Embolization System. The proposed clinical study is a non-randomized, multi-center, prospective confirmatory study to assess the safety and efficacy of the WEB Aneurysm Embolization System.
Trial website
nil
Trial related presentations / publications
Klisch, J., Sychra., Vojtech, S., Strasilla, C., Liebig, T., & Fiorella, D. (2011). The Woven endobridge cerebral aneurysm embolization Device (WEB II): Initial clinical experience. Neuroradiol, 53, 599-607.

Ding, Y. H., Lewis, D. A., Kadirvel, R., Dai, D., & Kallmes, D. F. (2011). The Woven endobridge: A New aneurysm occlusion device. AJNR, 32.
Public notes

Contacts
Principal investigator
Name 33982 0
Address 33982 0
Country 33982 0
Phone 33982 0
Fax 33982 0
Email 33982 0
Contact person for public queries
Name 17229 0
Kathy Akagha, MPH
Address 17229 0
11A Columbia
Aliso Viejo, CA 92565
Country 17229 0
United States of America
Phone 17229 0
+1 949-830-9600 X 127
Fax 17229 0
Email 17229 0
[email protected]
Contact person for scientific queries
Name 8157 0
Amy Walters
Address 8157 0
11A Columbia
Aliso Viejo, CA 92565
Country 8157 0
United States of America
Phone 8157 0
+1 949-830-9600 X 121
Fax 8157 0
Email 8157 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.