St. Jude Medical Angio-Seal VIP Vascular Closure Device

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01393041
First received: June 22, 2011
Last updated: August 10, 2012
Last verified: August 2012
  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: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: No ]
  • Rate of minor vascular complications [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01393041

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

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01393041     History of Changes
Other Study ID Numbers: 0901
Study First Received: June 22, 2011
Last Updated: August 10, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on September 11, 2014