Trials / Recruiting
RecruitingNCT06445608
PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm
PICANTE: PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 310 (estimated)
- Sponsor
- Kardion Inc · Industry
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
This purpose of this trial is to demonstrate 30 day safety and effectiveness outcomes of the KARDION CORY P4 System in subjects who require hemodynamic support during a high-risk PCI procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Percutaneous Mechanical Circulatory Support | Patients are randomized to receive one of two types of percutaneous mechanical circulatory support devices during a high-risk PCI procedure. |
Timeline
- Start date
- 2024-09-03
- Primary completion
- 2025-12-01
- Completion
- 2025-12-01
- First posted
- 2024-06-06
- Last updated
- 2025-06-13
Locations
18 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06445608. Inclusion in this directory is not an endorsement.