Angio-Seal Evolution Device Registry

February 1, 2019 updated by: Abbott Medical Devices

Clinical Registry of the St. Jude Medical Angio-Seal(TM) Evolution(TM) Vascular Closure Device Following Diagnostic and/or Interventional Endovascular Procedures

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

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

1004

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90017
        • Good Samaritan Hospital
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Michigan Heart, P.C.
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper Health System
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Baptist Medical Center
    • North Dakota
      • Grand Forks, North Dakota, United States, 58201
        • Altru Health System Hospital
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Ohiohealth Research Institute @ Riverside Methodist Hospital
    • Oregon
      • Portland, Oregon, United States, 97225
        • Providence Health & Services
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Main Line Health Heart Center: Bryn Mawr Hospital
      • Wynnewood, Pennsylvania, United States, 19096
        • Main Line Health Heart Center: Lankenau Hospitals
    • Tennessee
      • Knoxville, Tennessee, United States, 37934
        • Baptist Hospital West

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Those needing a diagnostic and/or interventional catheterization procedure.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Collect major vascular complications
Time Frame: 30 days post-procedure
30 days post-procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess time artery stops bleeding
Time Frame: Immediately following procedure
Immediately following procedure
Collect minor vascular complications
Time Frame: 30 days post-procedure
30 days post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Robert Applegate, MD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

January 5, 2009

First Submitted That Met QC Criteria

January 5, 2009

First Posted (Estimate)

January 6, 2009

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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