NCT01393041|Completed
St. Jude Medical Angio-Seal VIP Vascular Closure Device
Clinical Study of the St. Jude Medical Angio-Seal VIP Vascular Closure Device Following Diagnostic and/or Interventional Endovascular Procedures
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Clinical Study of the St. Jude Medical Angio-Seal VIP Vascular Closure Device Following Diagnostic and/or Interventional Endovascular Procedures
Sponsor study identifier
interventional
50
1 country
1
Study Start
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2011
Actual (reported)Study Completion
December 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
June 22, 2011
Actual (reported)July 2011
Actual (reported)July 13, 2011
Actual (reported)December 2011
Actual (reported)Device deployment characteristics and performance
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.
At procedure
Adverse events (vascular complications)
Adverse events (vascular complications) out to 30 days post-procedure on patients who have undegone a diagnostic and/or interventional procedure.
Ongoing
Time to hemostasis
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
Ongoing
Vascular Closure Device
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Klinikum Luedenscheid
Lüdenscheid, Germany
50 participants (actual enrollment reported by the registry).
First Submitted
June 22, 2011
First Posted
July 13, 2011
Study Start
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
July 2011
Actual (reported)Study Completion
December 2011
Actual (reported)Last Updated
February 4, 2019
Record last verified: 2019-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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