Clinical Investigation for Safety and Efficacy Study of CELT ACD (Arterial ClosureDevice)
|ClinicalTrials.gov Identifier: NCT01600482|
Recruitment Status : Completed
First Posted : May 17, 2012
Results First Posted : August 23, 2017
Last Update Posted : August 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Disease Coronary Artery Disease||Device: CELT ACD||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||241 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Clinical Investigation Plan (CIP) for Safety and Efficacy Study of Arterial Closure Device (CELT ACD). Clinical Investigation Plan No.: CIP-TS-003|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
Experimental: CELT ACD device
The CELT ACD device is a vascular closure device.
Device: CELT ACD
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.
No Intervention: Manual Compression
- The Primary Safety Endpoint Will be the Combined Rate of Major Complications With in 30 +/- 7 Days Following the Percutaneous Coronary Intervention (PCI) Procedure. [ Time Frame: With in the first 30 days +/- 7 days following the procedure ]rate of major complications with in 30 +/- 7 days following the PCI procedure.
- The Primary Effectiveness Endpoint Will be Time to Hemostasis (TTH) [ Time Frame: With in the first 30 days +/- 7 days following the procedure ]Time to hemostasis
- The Secondary Safety Endpoint Will be the 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 ]combined rate of minor complications with in 30 +/- 7 days following procedure.
- Time to Ambulation [ Time Frame: With in the first 30 days +/- 7 days following the procedure ]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 to Discharge-ability [ Time Frame: 30 days +/- 7 days ]Time to discharge-ability
- Procedure Success [ Time Frame: 30 days +/- 7 days ]Procedure Success 30 days +/- 7 days
- Device Success [ Time Frame: 30 days +/- 7 days ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01600482
|United States, New Jersey|
|Cooper University Hospital|
|Camden, New Jersey, United States, 08103|
|United States, New York|
|New York Presbyterian Hospital|
|New York, New York, United States, 10021|
|Städtische Kliniken Neuss - Lukaskrankenhaus - GmbH|
|Preußenstr. 84,41464 Neuss, Neuss, Germany, 41464 Neuss|
|Charite Campus Mitte|
|Berlin, Germany, 10117|
|Galway University Hosptial|