St. Jude Medical Angio-Seal VIP Vascular Closure Device
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Condition or disease
Patients Requiring a Diagnostic and/or Interventional Diagnostic 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.
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 Outcome Measures
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. ]
Rate of minor vascular complications [ Time Frame: Ongoing ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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).