Post-Market Study of the St. Jude Medical Angio-Seal™ V-Twist Integrated Platform (VIP) Vascular Closure Device (SEAL PM)

Abbott

Status: Completed

Conditions: Vascular Closure

Treatments: Device: Angio-Seal VIP 6 French (6F) and 8 French (8F) devices

Study type: Observational

Funder types: Industry

Identifiers

NCT01858636

CL06818

Details and patient eligibility

About

To characterize the clinical outcomes of Angio-Seal VIP with St. Jude Medical (SJM) collagen through the collection of device/procedure-related major vascular complications and time to hemostasis.

Enrollment: 235 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient requires closure of femoral artery puncture resulting from arterial access procedure.
• Patient is ≥18 years of age.
• Patient is willing to provide written informed consent prior to study device use.
• Patient is willing and able to adhere to data collection and follow-up requirements.

Exclusion criteria

• Patient is participating in another clinical trial which has the potential to impact hemostasis.
• Patient has an active groin infection or systemic infection.
• Patient has undergone a vascular access procedure within the past 90 days.
• Patient has been previously enrolled in the study. (For patients undergoing multiple interventions within a timeframe of 90 days, only the initial procedure may constitute a study enrollment.)

Trial design

235 participants in 1 patient group

Angio-Seal VIP Vascular Closure

Treatment:

Device: Angio-Seal VIP 6 French (6F) and 8 French (8F) devices