The PROTECT-EU Study

NCT ID: NCT05466552

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 859 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-18
• Study Completion Date: 2024-06-01

Brief Summary

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.

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.

Conditions

High-risk PCI

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

PCI procedure

During the PCI procedure, use of ECMO/Impella 5.0 is allowed hemodynamic instability (bail- out).

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abiomed Inc.

INDUSTRY

Sponsor Role: collaborator

University of Padova

OTHER

Sponsor Role: collaborator

Fondazione GISE Onlus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ospedale San Raffaele

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Vega Rusconi, MD

Role: primary

rusconi.vega@hsr.it

+390226437331 (9327 direct)

Other Identifiers

GISE_PROTECTEU

Identifier Type: -

Identifier Source: org_study_id