Status:
COMPLETED
Post-Market Study of the St. Jude Medical Angio-Seal™ V-Twist Integrated Platform (VIP) Vascular Closure Device
Lead Sponsor:
Abbott Medical Devices
Conditions:
Vascular Closure
Eligibility:
All Genders
18+ years
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.
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
235 Patients enrolled
Trial Details
Trial ID
NCT01858636
Start Date
May 1 2013
End Date
October 1 2013
Last Update
February 5 2019
Active Locations (6)
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1
Kerckhoff-Klinik GmbH
Bad Nauheim, Germany
2
Institut für Diagnostiche und Interventionelle Radiologie
Frankfurt, Germany
3
Univ. des Saarlandes
Homburg, Germany
4
Herzzentrum Leipzig GMBH
Leipzig, Germany