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
* 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.
Study Type
OBSERVATIONAL
Enrollment
81
TransForm™ Occlusion Balloon Catheter
Desert Regional Medical Center
Palm Springs, California, United States
Central Baptist Hospital
Lexington, Kentucky, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Catheters Visualized That Reached Intended Target
The number of TransForm™ OBC catheters that reached the intended target location confirmed by angiography visualization.
Time frame: intra-procedure
Angiographic Assessment on Catheter
Visibility of TransForm™ OBC on angiography
Time frame: intra-procedure
Procedural Technical Success
Ability of TransForm™ OBC to Perform as Intended
Time frame: post-procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
West Virginia University
Morgantown, West Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Hospital Universitario Donostia
Donostia / San Sebastian, Spain