Clinical Study of the St. Jude Medical Angio-Seal VIP Vascular Closure Device Following Diagnostic and/or Interventional Endovascular Procedures
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Adverse events (vascular complications)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Angio-Seal VIP
Intervention: Angio-Seal VIP (Device)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- 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)