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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
* 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.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
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
West Virginia University
Morgantown, West Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Hospital Universitario Donostia
Donostia / San Sebastian, Spain
Start Date
December 1, 2013
Primary Completion Date
January 1, 2015
Completion Date
January 1, 2015
Last Updated
September 6, 2019
81
ACTUAL participants
TransForm™ Occlusion Balloon Catheter
DEVICE
Lead Sponsor
Stryker Neurovascular
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT02191618