TransForm™ Occlusion Balloon Catheter Registry
This study is currently recruiting participants.
Verified September 2013 by Stryker Neurovascular
Information provided by (Responsible Party):
First received: September 20, 2013
Last updated: January 6, 2014
Last verified: September 2013
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
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Target Follow-Up Duration:||1 Day|
Further study details as provided by Stryker Neurovascular:
Primary Outcome Measures:
- The ability of the TransForm™ Occlusion Balloon Catheter to reach the target site. [ Time Frame: Day 1 of the index procedure ] [ Designated as safety issue: No ]
|Study Start Date:||November 2013|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
- 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.
- Approximately 70 subjects will be enrolled at up to 7 study sites (approximately 5 sites in the United States and 2 sites internationally). Each site will be allowed to enroll up to a maximum subject of 15 subjects per site.
- Enrollment in the registry occurs after a signed Informed Consent Form has been obtained, and the index procedure starts.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01949779
|United States, Kentucky|
|Lexington, Kentucky, United States|
|Contact: Sara Birk 859-260-6950 firstname.lastname@example.org|
|Principal Investigator: Curtis Given|
|United States, Ohio|
|The Ohio State University Wexner Medical Center||Recruiting|
|Columbus, Ohio, United States|
|Contact: kathy Jelinek 614-688-6853 Kathryn.Jelinek@osumc.edu|
|Principal Investigator: Eric Sauvageau|
|United States, West Virginia|
|West Virginia University||Recruiting|
|Morgantown, West Virginia, United States|
|Contact: Jennifer Domico 304-598-6930 email@example.com|
|Principal Investigator: Ansaar Rai|
Sponsors and Collaborators