Registry evaluating outcomes in high-risk PCI patients using Impella support
A Prospective Multinational Registry on Preventive Left Ventricular Support With Impella in Anatomically High-risk PCI Treated Patients
This study is testing how well the Impella device works to support high-risk heart patients during a special heart procedure called PCI to see if it helps them recover better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 859 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fondazione GISE Onlus Academic / other |
| Locations | 1 site (Milano) |
| Trial ID | NCT05466552 on ClinicalTrials.gov |
What this trial studies
The PROTECT-EU Registry is a prospective, non-randomized, multinational registry designed to assess the 90-day outcomes of patients undergoing high-risk percutaneous coronary intervention (PCI) with the support of the Impella CP® System. This study aims to confirm and enhance the effectiveness of the Impella device in a diverse population of high-risk patients who are not candidates for surgical revascularization. By collecting data on these patients, the registry seeks to provide insights into the safety and efficacy of preventive left ventricular support during PCI procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with chronic or acute coronary syndromes and reduced left ventricular ejection fraction (LVEF ≤ 40%) who require high-risk PCI.
Not a fit: Patients who are not undergoing high-risk PCI or those with LVEF above 40% may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve outcomes for high-risk PCI patients by demonstrating the effectiveness of the Impella device in preventing complications.
How similar studies have performed: Other studies have shown promising results with the use of Impella support in high-risk PCI, indicating that this approach has potential based on previous findings.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Milano
- Ospedale San Raffaele — Milano, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.