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Angio-Seal Evolution Device Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00817349
Recruitment Status : Completed
First Posted : January 6, 2009
Last Update Posted : April 27, 2010
Sponsor:
Information provided by:
St. Jude Medical

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

Condition or disease
Peripheral Vascular Disease Coronary Artery Disease Peripheral Artery Disease Arterial Occlusive Disease Coronary Heart Disease

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
Actual Enrollment : 1004 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Registry of the St. Jude Medical Angio-Seal(TM) Evolution(TM) Vascular Closure Device Following Diagnostic and/or Interventional Endovascular Procedures
Study Start Date : July 2008
Primary Completion Date : April 2010
Study Completion Date : April 2010



Primary Outcome Measures :
  1. Collect major vascular complications [ Time Frame: 30 days post-procedure ]

Secondary Outcome Measures :
  1. Assess time artery stops bleeding [ Time Frame: Immediately following procedure ]
  2. Collect minor vascular complications [ Time Frame: 30 days post-procedure ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Those needing a diagnostic and/or interventional catheterization procedure.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00817349


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vicki Bebeau, Senior Director of Clinical Research, St. Jude Medical
ClinicalTrials.gov Identifier: NCT00817349     History of Changes
Other Study ID Numbers: 0801
First Posted: January 6, 2009    Key Record Dates
Last Update Posted: April 27, 2010
Last Verified: April 2010

Keywords provided by St. Jude Medical:
Angio-Seal
Peripheral vascular disease
Vascular closure device
Arterial closure
Coronary artery disease
Arterial hemostasis
Coronary cardiac catheterization
Percutaneous coronary intervention
Interventional catheterization
Diagnostic catheterization
Common femoral artery
Manual compression
Vascular intervention
Angiogram
Coronary intervention
Coronary angioplasty
Angiography
Arteriotomy
Vascular access

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Cardiovascular Diseases
Arteriosclerosis
Atherosclerosis