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NCT00817349 Clinical Trial

Angio-Seal Evolution Device Registry

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00817349
Other study ID # 0801
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2008
Est. completion date April 2010

Study information
Verified date February 2019
Source Abbott Medical Devices
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 1004
Est. completion date April 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Main Line Health Heart Center: Bryn Mawr Hospital Bryn Mawr Pennsylvania
United States Cooper Health System Camden New Jersey
United States Ohiohealth Research Institute @ Riverside Methodist Hospital Columbus Ohio
United States Altru Health System Hospital Grand Forks North Dakota
United States Baptist Hospital West Knoxville Tennessee
United States Good Samaritan Hospital Los Angeles California
United States Providence Health & Services Portland Oregon
United States Wake Forest University Baptist Medical Center Winston-Salem North Carolina
United States Main Line Health Heart Center: Lankenau Hospitals Wynnewood Pennsylvania
United States Michigan Heart, P.C. Ypsilanti Michigan

Sponsors (1)
Lead Sponsor Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Collect major vascular complications 30 days post-procedure
Secondary Assess time artery stops bleeding Immediately following procedure
Secondary Collect minor vascular complications 30 days post-procedure
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