Angio-Seal Evolution Device Registry

NCT ID: NCT00817349

Last Updated: 2019-02-04

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

COMPLETED

Total Enrollment

1004 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-04-30

Brief Summary

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Collect data on the use of the Angio-Seal Evolution Device in diagnostic and interventional patient populations.

Detailed Description

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This multi-center clinical registry is designed to collect data on the use of the Angio-Seal Evolution Device in patients who have had diagnostic and/or interventional procedures through femoral artery access. Data will be collected on a patient's initial screening through hospital discharge and 30 days post-procedure to evaluate major and minor vascular complications as defined in the protocol.

Conditions

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Peripheral Vascular Disease Coronary Artery Disease Peripheral Artery Disease Arterial Occlusive Disease Coronary Heart Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patient is having a diagnostic and/or interventional procedure via femoral artery access.

Exclusion Criteria

* Patients who are unable to provide written informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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St. Jude Medical

Principal Investigators

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Robert Applegate, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Good Samaritan Hospital

Los Angeles, California, United States

Site Status

Michigan Heart, P.C.

Ypsilanti, Michigan, United States

Site Status

Cooper Health System

Camden, New Jersey, United States

Site Status

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Site Status

Altru Health System Hospital

Grand Forks, North Dakota, United States

Site Status

Ohiohealth Research Institute @ Riverside Methodist Hospital

Columbus, Ohio, United States

Site Status

Providence Health & Services

Portland, Oregon, United States

Site Status

Main Line Health Heart Center: Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States

Site Status

Main Line Health Heart Center: Lankenau Hospitals

Wynnewood, Pennsylvania, United States

Site Status

Baptist Hospital West

Knoxville, Tennessee, United States

Site Status

Countries

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United States

References

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Applegate RJ, Turi Z, Sachdev N, Ahmed A, Szyniszewski A, Foster M, Pratsos A, Shapiro T, Yakubov S, Shavelle D. The Angio-Seal Evolution registry: outcomes of a novel automated Angio-Seal vascular closure device. J Invasive Cardiol. 2010 Sep;22(9):420-6.

Reference Type DERIVED
PMID: 20814049 (View on PubMed)

Other Identifiers

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0801

Identifier Type: -

Identifier Source: org_study_id

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