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Clinical Trials/ACTRN12612000439842
ACTRN12612000439842
Recruiting
未知

An observational study to assess the progress of basilar apex aneurysms after treatment with the WEB Aneurysm Embolization System

Sequent Medical, Inc.0 sites50 target enrollmentApril 18, 2012
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ConditionsIntracranial wide-neck basilar apex aneurysmsNeurological - Other neurological disordersCardiovascular - Hypertension

Overview

Phase
未知
Intervention
Not specified
Conditions
Intracranial wide-neck basilar apex aneurysms
Sponsor
Sequent Medical, Inc.
Enrollment
50
Status
Recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 18, 2012
End Date
TBD
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sequent Medical, Inc.

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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