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NCT00732628 Clinical Trial

Evaluating Outcomes in the Placement of Boomerang Percutaneous Device

Medical Device Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00732628
Other study ID # HUM13883
Secondary ID
Status Terminated
Phase N/A
First received July 25, 2008
Last updated February 20, 2009
Start date January 2008
Est. completion date September 2008

Study information
Verified date February 2009
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 200
Est. completion date September 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• Boomerang closure device
Use of percutaneous of Boomerang closure device. Follow up outcomes evaluated after the use of Boomerang closure device.

Locations
Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (1)
Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

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