NCT00562016

Protect II, A Prospective, Multicenter Randomized Controlled Trial

PROTECT II: A Prospective, Multi-center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump (IABP)in Patients Undergoing Non Emergent High Risk PCI

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 452 (actual)
• Sponsor: Abiomed Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The IMPELLA® 2.5 System will be superior to Intra Aortic Balloon Pump in preventing the composite rate of major adverse events during and after the PCI procedure.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	IMPLELLA LP 2.5	Insertion of the LP 2.5 IMPELLA circulatory support system that can be placed across the aortic valve using a single femoral site. The device pumps blood from the left ventricle into the ascending aorta at 2.5 L/min.
DEVICE	IABP Intra-aortic balloon pump	IABP uses counterpulsation to provide 0.2L/min coronary flow

Timeline

• Start date: 2007-10-01
• Primary completion: 2011-04-01
• Completion: 2011-09-01
• First posted: 2007-11-21
• Last updated: 2011-03-21

Locations

50 sites across 3 countries: United States, Canada, Netherlands