PROTECT I, A Prospective Feasibility Trial Investigating the Use of IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI

Abiomed

Status and phase: Completed; Phase 2

Conditions: Patients Undergoing High Risk PCI.

Treatments: Device: High Risk PCI

Study type: Interventional

Funder types: Industry

Identifiers

NCT00534859

G050017

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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
• EF <35%

Exclusion criteria

• ST Myocardial Infarction
• Cardiac Arrest
• Cardiogenic Shock
• Thrombus Left Ventricle

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)