The PROTECT-EU Study

NCT05466552 | Recruiting DMC

• 1 other identifier: GISE_PROTECTEU
• Study Type: observational
• Target: 859
• Locations: 1 country
• Sites: 1

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.

Conditions

High-risk PCI

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• hospitalization for cardiovascular cause

  at 90 days

• hospitalization for cardiovascular cause

  at 1 year

• cerebrovascular events

  at 90 days

• cerebrovascular events

  at 1 year

• QoL: KCCQ

  at 90 days

Interventions

PCI procedure PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione GISE Onlus: lead
• Abiomed Inc.: collaborator
• University of Padova: collaborator

Study Sites (1)

Ospedale San Raffaele

Milan, Italy

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: July 20, 2022
• Study Start: October 18, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)