TransForm™ Occlusion Balloon Catheter Registry

August 26, 2019 updated by: Stryker Neurovascular
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

81

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

primary care/hospitals

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TransForm™ Occlusion Balloon Catheter
Device: TransForm™ Occlusion Balloon Catheter
TransForm™ Occlusion Balloon Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Catheters Visualized That Reached Intended Target
Time Frame: intra-procedure
The number of TransForm™ OBC catheters that reached the intended target location confirmed by angiography visualization.
intra-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Angiographic Assessment on Catheter
Time Frame: intra-procedure
Visibility of TransForm™ OBC on angiography
intra-procedure
Procedural Technical Success
Time Frame: post-procedure
Ability of TransForm™ OBC to Perform as Intended
post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stryker Neurovascular

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

September 20, 2013

First Submitted That Met QC Criteria

September 23, 2013

First Posted (Estimate)

September 25, 2013

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

August 26, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T4023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intracranial Aneurysms

Clinical Trials on TransForm™ Occlusion Balloon Catheter

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe