- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00817349
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
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
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California
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Los Angeles, California, United States, 90017
- Good Samaritan Hospital
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Michigan
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Ypsilanti, Michigan, United States, 48197
- Michigan Heart, P.C.
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New Jersey
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Camden, New Jersey, United States, 08103
- Cooper Health System
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Baptist Medical Center
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North Dakota
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Grand Forks, North Dakota, United States, 58201
- Altru Health System Hospital
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Ohio
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Columbus, Ohio, United States, 43214
- Ohiohealth Research Institute @ Riverside Methodist Hospital
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Oregon
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Portland, Oregon, United States, 97225
- Providence Health & Services
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Pennsylvania
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Bryn Mawr, Pennsylvania, United States, 19010
- Main Line Health Heart Center: Bryn Mawr Hospital
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Wynnewood, Pennsylvania, United States, 19096
- Main Line Health Heart Center: Lankenau Hospitals
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Tennessee
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Knoxville, Tennessee, United States, 37934
- Baptist Hospital West
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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
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.
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
- Coronary artery disease
- Peripheral vascular disease
- Percutaneous coronary intervention
- Angiography
- Coronary intervention
- Coronary angioplasty
- Vascular access
- Vascular closure device
- Angio-Seal
- Angiogram
- Arterial closure
- Arterial hemostasis
- Coronary cardiac catheterization
- Interventional catheterization
- Diagnostic catheterization
- Common femoral artery
- Manual compression
- Vascular intervention
- Arteriotomy
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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