Completed
Clinical Study of the St. Jude Medical Angio-Seal VIP Vascular Closure Device Following Diagnostic and/or Interventional Endovascular Procedures
What is being tested
Angio-Seal VIP
Device
Who is being recruted
Over 18 Years
+8 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: June 2011
Summary
Principal SponsorAbbott Medical Devices
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2011
Actual date on which the first participant was enrolled.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.
Official TitleClinical Study of the St. Jude Medical Angio-Seal VIP Vascular Closure Device Following Diagnostic and/or Interventional Endovascular Procedures
Principal SponsorAbbott Medical Devices
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
4 inclusion criteria required to participate
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.
4 exclusion criteria prevent from participating
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).
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
CompletedOne Study Center