Trials / Unknown
UnknownNCT05466552
The PROTECT-EU Study
A Prospective Multinational Registry on Preventive Left Ventricular Support With Impella in Anatomically High-risk PCI Treated Patients
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 859 (estimated)
- Sponsor
- Fondazione GISE Onlus · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- —
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | PCI procedure | During the PCI procedure, use of ECMO/Impella 5.0 is allowed hemodynamic instability (bail- out). |
Timeline
- Start date
- 2022-10-18
- Primary completion
- 2024-06-01
- Completion
- 2024-06-01
- First posted
- 2022-07-20
- Last updated
- 2024-03-04
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT05466552. Inclusion in this directory is not an endorsement.