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TransForm™ Occlusion Balloon Catheter Registry

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular
ClinicalTrials.gov Identifier:
NCT01949779
First received: September 20, 2013
Last updated: January 13, 2015
Last verified: October 2014
  Purpose

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 ]

Enrollment: 81
Study Start Date: November 2013
Study Completion Date: January 2015
Primary Completion Date: January 2015 (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.
  • 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.
  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT01949779

Locations
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
Spain
Hospital Universitario Donostia
San Sebastian, Spain
Sponsors and Collaborators
Stryker Neurovascular
  More Information

No publications provided

Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT01949779     History of Changes
Other Study ID Numbers: T4023
Study First Received: September 20, 2013
Last Updated: January 13, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 30, 2015