Trial record 1 of 5 for:    transform occlusion
Previous Study | Return to List | Next Study

TransForm™ Occlusion Balloon Catheter Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01949779
Recruitment Status : Completed
First Posted : September 25, 2013
Last Update Posted : January 15, 2015
Information provided by (Responsible Party):
Stryker Neurovascular

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

Condition or disease Intervention/treatment
Neurointerventional Procedure 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.
  • 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 [Patient Registry]
Actual Enrollment : 81 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Study Start Date : November 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Group/Cohort Intervention/treatment
TransForm OBC Device: TransForm Occlusion Balloon Catheter

Primary Outcome Measures :
  1. The ability of the TransForm™ Occlusion Balloon Catheter to reach the target site. [ Time Frame: Day 1 of the index procedure ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01949779

United States, California
Desert Regional Medical Center
Palm Springs, California, United States, 92262
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26505
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Hospital Universitario Donostia
San Sebastian, Spain
Sponsors and Collaborators
Stryker Neurovascular

Responsible Party: Stryker Neurovascular Identifier: NCT01949779     History of Changes
Other Study ID Numbers: T4023
First Posted: September 25, 2013    Key Record Dates
Last Update Posted: January 15, 2015
Last Verified: October 2014