Evaluating Outcomes in the Placement of Boomerang Percutaneous Device

Terminated

• Conditions: Medical Device; Angiography
• Interventions: Device: Boomerang closure device

• Registration Number: NCT00732628
• Lead Sponsor: University of Michigan

Brief 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.

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 Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-08-07
• Study First Posted: 2008-08-12
• Study Completion: 2008-09
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-20
• Last Update Posted: 2009-02-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Boomerang percutaneous closure unit	Boomerang closure device	patients having a Boomerang percutaneous closure device after a Neurointerventional study

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States