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

January 5, 2009
April 23, 2010
July 2008
April 2010   (final data collection date for primary outcome measure)
Collect major vascular complications [ Time Frame: 30 days post-procedure ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00817349 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Angio-Seal Evolution Device Registry
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Those needing a diagnostic and/or interventional catheterization procedure.

  • Peripheral Vascular Disease
  • Coronary Artery Disease
  • Peripheral Artery Disease
  • Arterial Occlusive Disease
  • Coronary Heart Disease
Not Provided
Not Provided
Applegate RJ, Turi Z, Sachdev N, Ahmed A, Szyniszewski A, Foster M, Pratsos A, Shapiro T, Yakubov S, Shavelle D. The Angio-Seal Evolution registry: outcomes of a novel automated Angio-Seal vascular closure device. J Invasive Cardiol. 2010 Sep;22(9):420-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1004
April 2010
April 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00817349
0801
No
Vicki Bebeau, Senior Director of Clinical Research, St. Jude Medical
St. Jude Medical
Not Provided
Principal Investigator: Robert Applegate, MD Wake Forest School of Medicine
St. Jude Medical
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP