The PROTECT-EU Study

A Prospective Multinational Registry on Preventive Left Ventricular Support With Impella in Anatomically High-risk PCI Treated Patients

The PROTECT-EU Registry is a prospective, non-randomized, multi-national registry to evaluate 90 days outcomes in high risk-PCI (Percutaneous coronary intervention) patients treated with a preventive strategy with Impella CP® System.

Study Overview

• Status: Recruiting
• Conditions: High-risk PCI
• Intervention / Treatment: Procedure: PCI procedure

Detailed Description

The PROTECT-EU Registry is a prospective multinational registry on preventive left ventricular support with Impella in high-risk PCI treated patients. The aim is to confirm and improve the Impella effectiveness in a selected all comers high risk population undergoing supported HR-PCI (high risk-PCI) with Impella implantation before PCI.

• Study Type: Observational
• Enrollment (Estimated): 859

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy
    • Recruiting
    • Ospedale San Raffaele
    • Sub-Investigator: Alaide Chieffo
    • Contact: Vega Rusconi, MD; Phone Number: +390226437331 (9327 direct); Email: rusconi.vega@hsr.it
    • Principal Investigator: Matteo Montorfano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

High-risk PCI population defined with clinical and angiographic criteria. Impella will be started after coronary angiography and before PCI and will be discontinued before discharge from the catheterization laboratory if the patient is deemed hemodynamically stable. All subjects will have 1-year follow-up. The primary endpoint will be assessed at 90 days follow-up.

Description

Inclusion Criteria:

Patients with non-emergent chronic or acute coronary syndromes (the former refused from surgical revascularization) with reduced LVEF (left ventricular ejection fraction)(<=40%) and indication for high-risk PCI AND

Intended high-risk PCI defined as having at least one of the following criteria:

• Unprotected left main distal disease involving bifurcation or trifurcation or left main equivalent
• Diffuse degenerated (>5 mm) saphenous vein grafts involving the proximal or distal anastomosis or in-stent restenosis
• LAD (left anterior descending) long lesions (>48 mm) involving both septal and diagonal branches requiring multiple and overlapping stents
• Diffuse and severely calcified lesions (see protocol definition) with need for debulking devices (directional, rotational, orbital, and laser)
• Last patent conduit
• Complex CTO (chronic total occlusion) (J-CTO score 3) or CTO in patients with MVD (Coronary Microvascular Disease)
• MV-PCI (Multivessel Percutaneous Coronary Intervention) in patient with a Syntax score>32 undergoing planned complete revascularization (see protocol definition of severe stenosis)
• (only in ACS Acute Coronary Syndrome patients) Giant thrombus (length ≥3x vessel diameter) in the context of MVD or Syntax score >32.

Exclusion Criteria:

• Classic CS Coronary Sinus (relative hypotension as SBP < 90 mmHg, or MAP <60 mmHg or >30 mmHg drop from baseline and drugs/device used to maintain blood pressure above these targets and/or symptoms/signs of hypoperfusion as cardiac index <2.2, lactate ≥ 2mmol/L (24).
• Cardiac arrest
• Patients admitted for ACS due to ST-elevation MI (ST Elevation Myocardial Infarction)
• Contraindication to Impella positioning: mural thrombus in the left ventricle; presence of a mechanical aortic valve; severe aortic stenosis or valvular regurgitation; severe peripheral arterial disease precluding placement of the Impella System; haematological disorder causing fragility of the blood cells or hemolysis; hypertrophic obstructive cardiomyopathy (HOCM); aneurysm or severe anomaly of the ascending aorta and/or aortic arch; significant right heart failure; presence of an atrial or ventricular sepal defect (including post-infarct VSD Ventricular Septal Defect); left ventricular rupture; cardiac tamponade; recent TIA or stroke (within 1 month); contraindication to anticoagulation
• Age < 18 or > 80 years old
• Inability to understand and sign informed consent
• Serious known concomitant disease with a life expectancy of less than one year
• Prior thrombolytic therapy during the index event (within 72 h of presentation)
• Severe renal impairment Renal insufficiency (GFR Glomerular Filtration Rate <30 ml/min)
• Patients on oral anticoagulation therapy (including novel oral anticoagulant such as dabigatran, rivaroxaban, apixaban and edoxaban) at the time of PCI
• Suspected or known pregnancy
• Suspected active infection
• Current participation in an investigational study using a drug or device.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Composite endpoint of all-cause death	at 90 days
Cerebrovascular accident	Cerebrovascular accident at 90 days	at 90 days
infarction	myocardial infarction	at 90 days
revascularization	repeat revascularization	at 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hospitalization for cardiovascular cause	cardiovascular disease	at 90 days
hospitalization for cardiovascular cause	cardiovascular disease	at 1 year
cerebrovascular events	cerebrovascular events (all, stroke and TIA)	at 90 days
cerebrovascular events	cerebrovascular events (all, stroke and TIA)	at 1 year
QoL: KCCQ	KCCQ (Kansas City Cardiomyopathy Questionnaire)	at 90 days
QoL: EQ-5D	EQ-5D: EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group to provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys.	at 90 days
QoL: KCCQ	KCCQ (Kansas City Cardiomyopathy Questionnaire)	at 1 year
QoL: EQ-5D	EQ-5D: EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group to provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys.	at 1 year

Collaborators and Investigators

• Sponsor: Fondazione GISE Onlus
• Collaborators: University of Padova; Abiomed Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: July 15, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: GISE_PROTECTEU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No