The objective of the CELT ACD® Vascular Closure Device study is to evaluate the safety and effectiveness of the CELT ACD® device to achieve hemostasis of the common femoral artery access site in patients on anticoagulation who are undergoing a percutaneous intervention (PCI) procedure using a 6F sheath.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
241
The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous intervention procedure using a 6F procedural sheath.
Cooper University Hospital
Camden, New Jersey, United States
New York Presbyterian Hospital
New York, New York, United States
Städtische Kliniken Neuss - Lukaskrankenhaus - GmbH
Preußenstr. 84,41464 Neuss, Neuss, Germany
Charite Campus Mitte
Berlin, Germany
The Primary Safety Endpoint Will be the Combined Rate of Major Complications With in 30 +/- 7 Days Following the Percutaneous Coronary Intervention (PCI) Procedure.
rate of major complications with in 30 +/- 7 days following the PCI procedure.
Time frame: With in the first 30 days +/- 7 days following the procedure
The Primary Effectiveness Endpoint Will be Time to Hemostasis (TTH)
Time to hemostasis
Time frame: With in the first 30 days +/- 7 days following the procedure
The Secondary Safety Endpoint Will be the Combined Rate of Minor Complications With in 30 +/- 7 Days Following Procedure.
combined rate of minor complications with in 30 +/- 7 days following procedure.
Time frame: With in the first 30 days +/- 7 days following the procedure
Time to Ambulation
Time to Ambulation (TTA) is defined as the time elapsed between sheath removal and time when the patient stands and walk 6m (20ft) without re-bleeding.
Time frame: With in the first 30 days +/- 7 days following the procedure
Time to Discharge-ability
Time to discharge-ability
Time frame: 30 days +/- 7 days
Procedure Success
Procedure Success 30 days +/- 7 days
Time frame: 30 days +/- 7 days
Device Success
Device Success (DS) is defined as the successful deployment of the Celt ACD device with the attainment of haemostasis and only assessed in the Celt ACD arm of the study.
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Galway University Hosptial
Galway, Ireland, Ireland
Time frame: 30 days +/- 7 days