Evaluating Outcomes in the Placement of Boomerang Percutaneous Device

February 20, 2009 updated by: University of Michigan

Technical and Clinical Outcomes Following Placement of Boomerang Percutaneous Closure Device After Cerebral Angiography or Neurointerventional Procedures

The purpose of this study is to evaluate the safety and effectiveness of the Boomerang percutaneous closure device following diagnostic cerebral angiography or neurointerventional procedures.

Background:

Very few publications have evaluated this relatively novel percutaneous closure device.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to document our experiences using the Boomerang closure device. Several different closure devices are used in the department of Radiology. A closure device is something that is placed in the artery in the leg just prior to removing the catheters from your leg at the end of the imaging or treatment procedure that is to be performed in the Department of Radiology. The devices used are all FDA approved. This study will compare the Boomerang device (a newer FDA approved device) to the other older devices currently being used. You may not have the Boomerang device used in your procedure; however, the Boomerang device is used in almost all of our patients undergoing a neuro imaging or treatment procedure. The neuroradiologist will determine which device if any is best for you based on the size of your artery, your medical condition etc. We will only collect data about you and your procedure if the Boomerang device is used.

Study Type

Observational

Enrollment (Anticipated)

200

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

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients having a neurointerventional procedure, such as a cerebral angiography

Description

Inclusion Criteria:

  • Any patient that has a percutaneous Boomerang closure device placed after having a neuro-intervention

Exclusion Criteria:

  • Patients that do not have this medical device used post procedure

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Boomerang percutaneous closure unit
patients having a Boomerang percutaneous closure device after a Neurointerventional study
Device: Boomerang closure device
Use of percutaneous of Boomerang closure device. Follow up outcomes evaluated after the use of Boomerang closure device.

Collaborators and Investigators

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

Sponsor

University of Michigan

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

January 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

July 25, 2008

First Submitted That Met QC Criteria

August 7, 2008

First Posted (Estimate)

August 12, 2008

Study Record Updates

Last Update Posted (Estimate)

February 24, 2009

Last Update Submitted That Met QC Criteria

February 20, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • HUM13883

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.

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