N/A
N=235
Post-Market Study of the St. Jude Medical Angio-Seal™ V-Twist Integrated Platform (VIP) Vascular Closure Device
Vascular Closure
Bottom Line
View on ClinicalTrials.gov: NCT01858636 ↗Enrolled (actual)
235
Serious AEs
16.1%
Results posted
Nov 2014
Primary outcome: Primary: The Percentage of Subjects Experiencing a Device or Procedure Related Major Vascular Complication — 2.8 % of subjects with MVCs — p=0.0029
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Angio-Seal VIP 6 French (6F) and 8 French (8F) devices (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Subjects Experiencing a Device or Procedure Related Major Vascular Complication |
2.8 | 0.0029 sig |
| PRIMARY The Percentage of Procedures Achieving Hemostasis Within 5 Minutes of Device Deployment. |
98.6 | <0.0001 sig |
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 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.)
Data sourced from ClinicalTrials.gov (NCT01858636). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.