NCT00732628

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2008

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 12, 2008

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

February 24, 2009

Status Verified

February 1, 2009

First QC Date

July 25, 2008

Last Update Submit

February 20, 2009

Conditions

Study Arms (1)

Boomerang percutaneous closure unit

patients having a Boomerang percutaneous closure device after a Neurointerventional study

Device: Boomerang closure device

Interventions

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

Boomerang percutaneous closure unit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients having a neurointerventional procedure, such as a cerebral angiography

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 25, 2008

First Posted

August 12, 2008

Study Start

January 1, 2008

Study Completion

September 1, 2008

Last Updated

February 24, 2009

Record last verified: 2009-02

Locations