NCT01949779

TransForm™ Occlusion Balloon Catheter Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 81 (actual)
• Sponsor: Stryker Neurovascular · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

* 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

• Intracranial Aneurysms

Interventions

Type	Name	Description
DEVICE	TransForm™ Occlusion Balloon Catheter	TransForm™ Occlusion Balloon Catheter

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2013-09-25
• Last updated: 2019-09-06
• Results posted: 2019-08-19

Locations

7 sites across 2 countries: United States, Spain