Status:
COMPLETED
Real World Use and Outcomes of VASCADE Closure Device Versus Manual Compression in Patients With CFA Disease
Lead Sponsor:
Yale University
Conditions:
Common Femoral Artery Stenosis
Eligibility:
All Genders
18-100 years
Brief Summary
To study the patient characteristics and outcomes associated with the real-world use of manual compression vs. vascular closure devices (VCDs) after common femoral artery (CFA) percutaneous access for...
Detailed Description
The overall objective of the study will be to examine the safety and efficacy of the VASCADE closure device compared to manual compression (standard of care) to achieve hemostasis after endovascular p...
Eligibility Criteria
Inclusion
- 5, 6 or 7 Fr access within the CFA
- ACT \< 300 seconds
- Age 18 - 90 years old
- Severe common femoral arterial disease Percent stenosis \> 50, which will be core-lab adjudicated
Exclusion
- Ipsilateral CFA access within 30 days preceding or subsequent to the index case
- Prior ipsilateral closure device use, other than VASCADE
- High bleeding risk ACT \> 300 or \> 250 with IIb/IIIa inhibitor Plt \< 50K INR \> 1.7 on the day of procedure Inherent coagulopathy NOAC, warfarin, or lovenox administered within 24 hours of the procedure
- Suspected intraluminal thrombus, dissection, pseudoaneurysm, hematoma, or AV Fistula
Key Trial Info
Start Date :
August 20 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04745624
Start Date
August 20 2020
End Date
December 1 2021
Last Update
February 3 2022
Active Locations (1)
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1
Yale University
New Haven, Connecticut, United States, 06519