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OpenTrials
Completed

NCT Number: NCT01393041

St. Jude Medical Angio-Seal VIP Vascular Closure Device

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.

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Key information

Conditions

Patients Requiring a Diagnostic and/or Interventional Diagnostic Procedure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Luedenscheid

Lüdenscheid, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Angio-Seal VIP

Device

Vascular Closure Device

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

  2. Rate of minor vascular complications

    Time frame: Ongoing

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Clinical Study of the St. Jude Medical Angio-Seal VIP Vascular Closure Device Following Diagnostic and/or Interventional Endovascular Procedures

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 13, 2011
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.