TransForm™ Occlusion Balloon Catheter Registry
1 other identifier
observational
81
2 countries
7
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2013
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2013
CompletedFirst Posted
Study publicly available on registry
September 25, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedResults Posted
Study results publicly available
August 19, 2019
CompletedSeptember 6, 2019
August 1, 2019
1.1 years
September 20, 2013
April 16, 2018
August 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Catheters Visualized That Reached Intended Target
The number of TransForm™ OBC catheters that reached the intended target location confirmed by angiography visualization.
intra-procedure
Secondary Outcomes (2)
Angiographic Assessment on Catheter
intra-procedure
Procedural Technical Success
post-procedure
Study Arms (1)
TransForm™ Occlusion Balloon Catheter
TransForm™ Occlusion Balloon Catheter
Interventions
TransForm™ Occlusion Balloon Catheter
Eligibility Criteria
primary care/hospitals
You may qualify if:
- 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.
You may not qualify if:
- Subject's anatomy precludes safe delivery of the TransForm Occlusion Balloon Catheter.
- Subject's pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Desert Regional Medical Center
Palm Springs, California, 92262, United States
Central Baptist Hospital
Lexington, Kentucky, 40503, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
West Virginia University
Morgantown, West Virginia, 26505, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Hospital Universitario Donostia
Donostia / San Sebastian, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Cheryl Fontana, Sr. Manager, Clinical Services
- Organization
- Stryker Neurovascular
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2013
First Posted
September 25, 2013
Study Start
December 1, 2013
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
September 6, 2019
Results First Posted
August 19, 2019
Record last verified: 2019-08