Post-Market Study of the St. Jude Medical Angio-Seal™ V-Twist Integrated Platform (VIP) Vascular Closure Device | NCT01858636 | Trialant
CompletedObservationalUpdated Feb 5, 2019
Post-Market Study of the St. Jude Medical Angio-Seal™ V-Twist Integrated Platform (VIP) Vascular Closure Device
ClinicalTrials.gov ID
NCT01858636
Lead Sponsor
Abbott Medical DevicesINDUSTRY
Overall Status
Completed
Study Type
Observational
Enrollment
235Actual
Last Update Posted
Feb 5, 2019Actual
Start Date
May 2013
Primary Completion Date
Oct 2013Actual
Completion Date
Oct 2013Actual
Brief Summary
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.
Vascular Closure
Angio-Seal VIP 6 French (6F) and 8 French (8F) devices
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Observational Model
Cohort
Time Perspective
Prospective
No central contacts
There are no central contacts for this study.
Kerckhoff-Klinik GmbH
Bad Nauheim, Germany
Institut für Diagnostiche und Interventionelle Radiologie