Clinical Investigation for Safety and Efficacy Study of CELT ACD (Arterial ClosureDevice)
NCT01600482 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 241
Last updated 2017-08-23
Summary
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.
Conditions
- Cardiac Disease
- Coronary Artery Disease
Interventions
- 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.
Sponsors & Collaborators
-
Vasorum Ltd
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-05-31
- Primary Completion
- 2016-02-29
- Completion
- 2016-02-29
Countries
- United States
- Germany
- Ireland
Study Locations
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