Coronary Artery Disease, Heart Failure With Reduced Ejection Fraction
Conditions
Keywords
Impella CP, Mechanical Circulatory Support, Protected PCI, High-Risk PCI, Hemodynamic Support, STRATUS-PCI
Brief summary
STRATUS-PCI is a pilot clinical trial that compares two ways of running a small heart pump called Impella CP during a high-risk procedure to open blocked heart arteries (percutaneous coronary intervention, or PCI) in patients with weakened heart muscle. The pump is placed temporarily through an artery in the leg and sits across the aortic valve to help maintain blood flow during the procedure. Fifty patients will be randomly assigned in equal numbers to one of two pump settings: an automatic mode that adjusts flow up to higher levels as needed, or a fixed lower-flow mode (P-2). The doctor performing the heart procedure will not know which setting is being used (double-blind). A separate doctor monitors blood pressure and is allowed to change the pump setting at any time if the patient becomes unstable. The main question is whether the automatic mode helps doctors complete the planned heart procedure more successfully and without drops in blood pressure or other complications. Results will help design a larger future trial.
Detailed description
STRATUS-PCI is an investigator-initiated, double-blind, randomized controlled pilot study evaluating two operating modalities of the Impella CP transvalvular axial-flow pump in patients undergoing protected complex high-risk percutaneous coronary intervention (PCI). Eligible participants are randomized 1:1 to either Impella CP Auto-mode (experimental) or Impella CP P-2 mode (active comparator, 1.3-2.1 L/min).
Interventions
DEVICEImpella CP
The Impella CP is a transvalvular axial-flow micro-pump for temporary mechanical circulatory support, inserted via a 14F sheath into the femoral artery and positioned across the aortic valve. The pump draws blood from the left ventricle and delivers it to the ascending aorta, providing forward flow up to approximately 4.3 L/min while reducing left ventricular work and end-diastolic pressure. In this study, the device is used in all participants undergoing protected high-risk PCI, with the operating modality (Auto-mode in the experimental arm vs. fixed P-2 mode in the active comparator arm) determined by 1:1 randomization. The unblinded study investigator may escalate Impella support if predefined hemodynamic instability criteria are met.
Sponsors
Rayyan Hemetsberger
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* signed written informed consent * age ≥ 18 years * presentation in chronic coronary syndrome or acute coronary syndrome (STEMI ≥ 24h) * LV-EF ≤ 40 % and one of the following parameters: Last remaining artery Unprotected LM-PCI + severe RCA stenosis or CTO Unprotected LM-PCI + left dominance Unprotected LM-PCI + severe aortic stenosis Unprotected LM-PCI + severe mitral regurgitation RCA PCI + unprotected severe LM stenosis RCA PCI + proximal LAD stenosis + proximal LCx stenosis
Exclusion criteria
* no written informed consent * pregnancy * acute infection * recent ST-elevation myocardial infarction (\< 24 hours) or not normalized CK-MB enzymes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Strategy Success | 48 hours | The primary endpoint is strategy success, defined as completing the procedure with successful uncomplicated PCI of all intended segments with a TIMI flow of 3 and residual stenosis of less than 30% without hemodynamic instability. Hemodynamic instability in our study is defined as 25 mmHg (as defined in past randomized studies) decrease on baseline mean arterial pressure (MAP) for longer than 1 minute or MAP of under 60 mmHg for longer than 1 minute, flat line, administration of any dose of catecholamines, change on Impella CP modality, periprocedural resuscitation and/or ventilation. Complications are defined as periprocedural resuscitation, emergency surgery, periprocedural ventilation, death, periprocedural myocardial infarction type 4a based on the 4th universal definition of myocardial infarction (35), periprocedural acute renal injury based on the 2012 KDIGO definition of acute kidney injury (36), bleeding BARC type 3 or 5. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 30 days | Proportion of participants who die from any cause within 30 days after the index protected high-risk PCI procedure. |
| Target lesion revascularization (TLR) | 30 days | Proportion of participants undergoing any clinically driven repeat revascularization (PCI or CABG) of the target lesion within 30 days after the index procedure. |
| Target vessel myocardial infarction (TV-MI) | 30 days | Proportion of participants with myocardial infarction attributable to the target vessel within 30 days after the index procedure, defined per the 4th Universal Definition of Myocardial Infarction. |
| Early stent thrombosis | 30 days | Proportion of participants with definite or probable stent thrombosis (per Academic Research Consortium criteria) within 30 days after the index procedure. |
Countries
Austria
Contacts
CONTACTRayyan Hemetsberger, MD
CONTACTKevin Hamzaraj, MD
STUDY_CHAIRSerdar Farhan, MD
Lennox Hill Hospital
Outcome results
None listed