Angio-Seal Evolution Device Registry

This study has been completed.
Sponsor:
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00817349
First received: January 5, 2009
Last updated: April 23, 2010
Last verified: April 2010
  Purpose

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


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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Collect major vascular complications [ Time Frame: 30 days post-procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess time artery stops bleeding [ Time Frame: Immediately following procedure ] [ Designated as safety issue: Yes ]
  • Collect minor vascular complications [ Time Frame: 30 days post-procedure ] [ Designated as safety issue: Yes ]

Enrollment: 1004
Study Start Date: July 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 School of Medicine
  More Information

No publications provided by St. Jude Medical

Additional 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
Study First Received: January 5, 2009
Last Updated: April 23, 2010
Health Authority: United States: Institutional Review Board

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:
Arterial Occlusive Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Arteriosclerosis
Atherosclerosis

ClinicalTrials.gov processed this record on September 11, 2014