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

Phase 2

Completed

• Conditions: Patients Undergoing High Risk PCI.

• Registration Number: NCT00534859
• Lead Sponsor: Abiomed Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2007-09-24
• Study First Submitted QC: 2007-09-24
• Study First Posted: 2007-09-26
• Primary Completion: 2010-06
• Status Verified: 2011-03
• Study Completion: 2011-03
• Last Update Submitted: 2011-03-18
• Last Update Posted: 2011-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
MACCE Events at 30 days or discharge, whichever is longer	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	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 Outcome Measures

Name	Time	Method
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	Freedom from the following procedural-related events: i. Ventricular fibrillation ii. Tachycardia requiring electrical cardioversion
Angiographic Success	Post-PCI	Angiographic success defined as residual stenosis \<30% after stent implantation or \<50% after balloon angioplasty.

Trial Locations

Locations (10)

William Beaumont; 🇺🇸 Royal Oak, Michigan, United States

UPMC Presbyterian Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Mass General Hospital; 🇺🇸 Boston, Massachusetts, United States

Brigham & Womens; 🇺🇸 Boston, Massachusetts, United States

Mt. Sinai School of Medicine; 🇺🇸 New York, New York, United States

Scripps; 🇺🇸 La Jolla, California, United States

Columbia Presbyterian Hospital; 🇺🇸 New York,, New York, United States

Texas Heart; 🇺🇸 Houston, Texas, United States

Academic Medical Center; 🇳🇱 Amsterdam, Netherland, Netherlands