TransForm™ Occlusion Balloon Catheter Registry

Intracranial Aneurysms Clinical Trial

Official title:

TransForm™ Occlusion Balloon Catheter Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01949779
• Other study ID #: T4023
• Status: Completed
• Start date: December 2013
• Est. completion date: January 2015

Study information

• Verified date: August 2019
• Source: Stryker Neurovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Intracranial Aneurysms

Intervention

Device:
• TransForm™ Occlusion Balloon Catheter
TransForm™ Occlusion Balloon Catheter

Locations

Country	Name	City	State
Spain	Hospital Universitario Donostia	San Sebastian
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	West Virginia University	Morgantown	West Virginia
United States	Desert Regional Medical Center	Palm Springs	California
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Neurovascular

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Angiographic Assessment on Catheter	Visibility of TransForm™ OBC on angiography	intra-procedure
Secondary	Procedural Technical Success	Ability of TransForm™ OBC to Perform as Intended	post-procedure