NCT01600482

Clinical Investigation for Safety and Efficacy Study of CELT ACD (Arterial ClosureDevice)

Clinical Investigation Plan (CIP) for Safety and Efficacy Study of Arterial Closure Device (CELT ACD). Clinical Investigation Plan No.: CIP-TS-003

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 241 (actual)
• Sponsor: Vasorum Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2012-05-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2012-05-17
• Last updated: 2017-08-23
• Results posted: 2017-08-23

Locations

5 sites across 3 countries: United States, Germany, Ireland