Coronairy artery disease stenotic vessels
Conditions
Interventions
Use of the pulsecath iVAC2L during high risk PCI
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age 18 or older - Multidisciplinary heart team consensus for MCS facilitated PCI AND - SCAI A-B AND - LVEF
Exclusion criteria
Exclusion criteria: - Contraindications for Pulsecath IVAC2L: a. Severe aortic regurgitation b. known presence of an LV thrombus (contrast echo/MRI) c. mechanical aortic valve prosthesis d. severe aortic valve stenosis e. peripheral arterial disease that would preclude placement of the PulseCath iVAC2L device - Cardiogenic shock defined as either SCAI CSWG stage C-E - Patient is intubated and mechanically ventilated - Stroke 35
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined endpoint 30 days: - All-cause death - SCAI stage C-E - Renal replacement therapy - Mechanical ventilation - -Peri or -postprocedural ventricular arrhythmias leading to loss of cardiac output | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy endpoints: - PCWP (Δ max) (Time Frame: periprocedural) - LVEDP (Δ max) (Time Frame: periprocedural) - CO / CI / CPO (Δ max) (Time Frame: periprocedural) - SvO2 (Time Frame: periprocedural) - Drop in SBP (SBP 10 minutes (Time Frame: periprocedural) - Highest Vasoactive Inotropic Score (Time Frame: hospitalisation) - Protected procedural sucess of Pulsecath iVAC2L [time Frame: Periprocedural] - Procedural success of Pulecath iVAC2L [time frame: | — |
Countries
Netherlands
Outcome results
None listed