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Evaluating Outcomes in the Placement of Boomerang Percutaneous Device

This study has been terminated.
(Physician is no longer associated with the Univ. of Michigan Medical Center)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00732628
First Posted: August 12, 2008
Last Update Posted: February 24, 2009
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.
Information provided by:
University of Michigan
  Purpose

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.


Condition Intervention
Medical Device Angiography Device: Boomerang closure device

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Technical and Clinical Outcomes Following Placement of Boomerang Percutaneous Closure Device After Cerebral Angiography or Neurointerventional Procedures

Further study details as provided by University of Michigan:

Estimated Enrollment: 200
Study Start Date: January 2008
Study Completion Date: September 2008
Groups/Cohorts Assigned Interventions
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.

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.
  Eligibility

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 and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients having a neurointerventional procedure, such as a cerebral angiography
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00732628


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
  More Information

Responsible Party: Sameer Ansari MD, University of Michigan
ClinicalTrials.gov Identifier: NCT00732628     History of Changes
Other Study ID Numbers: HUM13883
First Submitted: July 25, 2008
First Posted: August 12, 2008
Last Update Posted: February 24, 2009
Last Verified: February 2009