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Evaluating Outcomes in the Placement of Boomerang Percutaneous Device

NCT ID: NCT00732628

Last Updated: 2009-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Medical Device Angiography

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Boomerang percutaneous closure unit

patients having a Boomerang percutaneous closure device after a Neurointerventional study

Boomerang closure device

Intervention Type DEVICE

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

Interventions

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Boomerang closure device

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM13883

Identifier Type: -

Identifier Source: org_study_id

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