TransForm™ Occlusion Balloon Catheter Registry
- Conditions
- Intracranial Aneurysms
- Interventions
- Device: TransForm™ Occlusion Balloon Catheter
- Registration Number
- NCT01949779
- Lead Sponsor
- Stryker Neurovascular
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
- Subject or legal representative is willing and has provided informed consent.
- Subject is scheduled to undergo a neurointerventional procedure that may include the use of the occlusion balloon catheter.
- Subject is over 18 years of age.
- Subject's anatomy precludes safe delivery of the TransForm Occlusion Balloon Catheter.
- Subject's pregnant
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description TransForm™ Occlusion Balloon Catheter TransForm™ Occlusion Balloon Catheter TransForm™ Occlusion Balloon Catheter
- Primary Outcome Measures
Name Time Method Catheters Visualized That Reached Intended Target intra-procedure The number of TransForm™ OBC catheters that reached the intended target location confirmed by angiography visualization.
- Secondary Outcome Measures
Name Time Method Angiographic Assessment on Catheter intra-procedure Visibility of TransForm™ OBC on angiography
Procedural Technical Success post-procedure Ability of TransForm™ OBC to Perform as Intended
Trial Locations
- Locations (7)
Desert Regional Medical Center
🇺🇸Palm Springs, California, United States
Central Baptist Hospital
🇺🇸Lexington, Kentucky, United States
Hospital Universitario Donostia
🇪🇸San Sebastian, Spain
University of Massachusetts Medical School
🇺🇸Worcester, Massachusetts, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States