TransForm™ Occlusion Balloon Catheter Registry

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-01-31

Brief Summary

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The primary objective of this registry is to collect real world data on the safety and performance of the TransForm™ Occlusion Balloon Catheter when used in current neurointerventional procedures

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Detailed Description

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* This is a prospective, single-arm, non-randomized, multi-center, observational registry.
* The expected duration for study enrollment is approximately 6 months-1 year.
* Study participation for each subject will be completed upon removal of the guide catheter post-procedure.
* Up to 140 subjects will be enrolled at up to 15 study sites. A given site will be allowed to enroll a maximum of 20 subjects.
* Enrollment in the registry occurs after a signed Informed Consent Form has been obtained, and the index procedure starts.

Conditions

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Intracranial Aneurysms

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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TransForm™ Occlusion Balloon Catheter

Intervention Type DEVICE

TransForm™ Occlusion Balloon Catheter

Interventions

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TransForm™ Occlusion Balloon Catheter

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Subject or legal representative is willing and has provided informed consent.
2. Subject is scheduled to undergo a neurointerventional procedure that may include the use of the occlusion balloon catheter.
3. Subject is over 18 years of age.