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TransForm™ Occlusion Balloon Catheter Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Stryker Neurovascular
Information provided by (Responsible Party):
Stryker Neurovascular Identifier:
First received: September 20, 2013
Last updated: October 13, 2014
Last verified: October 2014

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

Condition Intervention
Neurointerventional Procedure
Device: TransForm Occlusion Balloon Catheter

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 ]

Estimated Enrollment: 70
Study Start Date: November 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
TransForm OBC Device: TransForm Occlusion Balloon Catheter

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.
  • 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.

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care/hospitals


Inclusion Criteria:

  1. Subject or legal representative is willing and has provided informed consent.
  2. Subject is scheduled to undergo a neurointerventional procedure that may include the use of the occlusion balloon catheter.
  3. Subject is over 18 years of age.

Exclusion Criteria:

  1. Subject's anatomy precludes safe delivery of the TransForm Occlusion Balloon Catheter.
  2. Subject's pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01949779

United States, California
Desert Regional Medical Center Completed
Palm Springs, California, United States, 92262
United States, Kentucky
Central Baptist Hospital Recruiting
Lexington, Kentucky, United States, 40503
Contact: Sara Renfrow    859-260-6950   
Principal Investigator: Curtis Given         
United States, Massachusetts
University of Massachusetts Medical School Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Mary Howk    774-441-8442   
Principal Investigator: Ajit Puri         
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Rebecca Duell    614-688-6853   
Principal Investigator: Ciaran Powers         
United States, West Virginia
West Virginia University Recruiting
Morgantown, West Virginia, United States, 26505
Contact: Jennifer Domico    304-598-6930   
Principal Investigator: Ansaar Rai         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Alicia Castonguay, Ph.D    414-805-5439   
Principal Investigator: Brian-Fred Fitzsimmons         
Hospital Universitario Donostia Recruiting
San Sebastian, Spain
Contact: Africa Madariaga    +34 911 159 645   
Principal Investigator: Javier Masso         
Sponsors and Collaborators
Stryker Neurovascular
  More Information

No publications provided

Responsible Party: Stryker Neurovascular Identifier: NCT01949779     History of Changes
Other Study ID Numbers: T4023
Study First Received: September 20, 2013
Last Updated: October 13, 2014
Health Authority: United States: Institutional Review Board processed this record on November 20, 2014