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.
Patients Requiring a Diagnostic and/or Interventional Diagnostic Procedure
Device: Angio-Seal VIP
|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|
- 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.
- 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 ]
|Study Start Date:||June 2011|
|Study Completion Date:||December 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01393041