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St. Jude Medical Angio-Seal VIP Vascular Closure Device

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01393041
First Posted: July 13, 2011
Last Update Posted: August 13, 2012
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.
Information provided by (Responsible Party):
St. Jude Medical
  Purpose
The purpose of this clinical study is to assess device deployment characteristics and performance, as well as adverse events (vascular complications) of the SJM Angio-Seal VIP 6 French device utilizing the SJM collagen.

Condition Intervention
Patients Requiring a Diagnostic and/or Interventional Diagnostic Procedure Device: Angio-Seal VIP

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of the St. Jude Medical Angio-Seal VIP Vascular Closure Device Following Diagnostic and/or Interventional Endovascular Procedures

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Device deployment characteristics and performance [ Time Frame: At procedure ]
    Device Deployment Success and rationale for non-deployment, procedural circumstances present during deployment such as type of procedure and procedure duration, Time to hemostasis, and assessment of vascular complications prior to leaving the cath lab. Data will be summarized using descriptive statistics in addition to listings or summary data tables being provided.

  • Adverse events (vascular complications) [ Time Frame: Ongoing ]
    Adverse events (vascular complications) out to 30 days post-procedure on patients who have undegone a diagnostic and/or interventional procedure.


Secondary Outcome Measures:
  • Time to hemostasis [ Time Frame: The time elapsed from device deployment (cutting of the suture) to complete cessation of arterial bleeding, stratified as hemostasis in less than 1 minute, 1-5 minutes, or greater than 5 minutes. ]
  • Rate of minor vascular complications [ Time Frame: Ongoing ]

Enrollment: 50
Study Start Date: June 2011
Study Completion Date: December 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Angio-Seal VIP Device: Angio-Seal VIP
Vascular Closure Device

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is undergoing a diagnostic and/or interventional endovascular procedure via a retrograde femoral arterial access.
  2. Patient is of legal age.
  3. Patient has given written informed consent for participation prior to the procedure.
  4. Patient is willing to undergo all study procedures and adhere to data collection and follow-up requirements.

Exclusion Criteria:

  1. Patient is unable to provide written informed consent.
  2. Patient has an inability or is unwilling to adhere to data collection and follow-up requirements.
  3. Patients who are pregnant or lactating.
  4. Patient may not participate in another clinical trial which has the potential to impact hemostasis (pharmaceutical/ device/ homeopathic).
  Contacts and Locations
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): NCT01393041


Locations
Germany
Klinikum Luedenscheid
Luedenscheid, Germany
Sponsors and Collaborators
St. Jude Medical
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01393041     History of Changes
Other Study ID Numbers: 0901
First Submitted: June 22, 2011
First Posted: July 13, 2011
Last Update Posted: August 13, 2012
Last Verified: August 2012