PROTECT I, A Prospective Feasibility Trial Investigating the Use of the IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Patients Undergoing High Risk PCI.
- Sponsor
- Abiomed Inc.
- Enrollment
- 28
- Locations
- 10
- Primary Endpoint
- MACCE Events at 30 days or discharge, whichever is longer
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed Informed Consent
- •Non emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft
Exclusion Criteria
- •ST Myocardial Infarction
- •Cardiac Arrest
- •Cardiogenic Shock
- •Thrombus Left Ventricle
Outcomes
Primary Outcomes
MACCE Events at 30 days or discharge, whichever is longer
Time Frame: 30 days or discharge
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.
Freedom from Hemodynamic compromise during PCI procedure
Time Frame: During procedure
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
Secondary Outcomes
- Other intra-procedural and peri-procedural adverse events(During treatment and out to 90 days)
- Freedom from Ventricular fibrillation and Tachycardia requiring electrical cardioversion(During procedure)
- Angiographic Success(Post-PCI)