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

Abiomed Inc.28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Patients Undergoing High Risk PCI.

Interventions

High Risk PCIDEVICE

High Risk Percutaneous Coronary Intervention

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (10)

Scripps

La Jolla, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Mass General Hospital

Boston, Massachusetts, United States

Brigham & Womens

Outcomes

Primary Outcomes

MACCE Events at 30 days or discharge, whichever is longer

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.

Time frame: 30 days or discharge

Freedom from Hemodynamic compromise during PCI 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

Time frame: During procedure

Secondary Outcomes

Other intra-procedural and peri-procedural adverse events

Time frame: During treatment and out to 90 days

Freedom from Ventricular fibrillation and Tachycardia requiring electrical cardioversion

Freedom from the following procedural-related events: i. Ventricular fibrillation ii. Tachycardia requiring electrical cardioversion

Time frame: During procedure

Angiographic Success

Angiographic success defined as residual stenosis \<30% after stent implantation or \<50% after balloon angioplasty.

Time frame: Post-PCI

Data from ClinicalTrials.gov

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