Completed
PHASE2
INTERVENTIONAL
NCT00534859
PROTECT I, A Prospective Feasibility Trial Investigating the Use of IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The objective of this feasibility study is to demonstrate that the device is safe and potentially efficacious for use in patients undergoing high risk Percutaneous Coronary Interventions(PCI).Patients will be enrolled if they meet inclusion \& exclusion criteria.
Interventions
Name:
High Risk PCI
Type:
DEVICE
Description:
High Risk Percutaneous Coronary Intervention
Primary Outcomes
Measure:
MACCE Events at 30 days or discharge, whichever is longer
TimeFrame:
30 days or discharge
Description:
Major Adverse Cardiac and Cerebral (MACCE) events defined as death, new myocardial infarction, target vessel revascularization, urgent coronary artery bypass grafting procedure or cerebral vascular accident during and up to 30 days post-device explant or hospital discharge, whichever is longer.
Measure:
Freedom from Hemodynamic compromise during PCI procedure
TimeFrame:
During procedure
Description:
Freedom from Hemodynamic compromise during PCI procedure defined as: Mean Arterial Pressure (MAP) not falling below 60mm Hg for more than 10 minutes during the PCI procedure and additional pressor medication is not required
Trial Information
NCT ID
NCT00534859
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
Abiomed Inc.
Last Updated
December 15, 2025