Actively Recruiting
Temporary MCS With the iVAC 2L Transaortic Device in High-risk PCI
Led by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation · Updated on 2025-09-08
100
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients with coronary artery disease and undergoing high-risk percutaneous coronary intervention (PCI) are at increased risk of hemodynamic instability and poor outcomes. Mechanical circulatory support (MCS) devices may offer hemodynamic stabilization during PCI, potentially improving short- and long-term outcomes. The study rationale is to investigate the safety and clinical efficacy of temporary MCS with the iVAC 2L transaortic device in high-risk percutaneous coronary intervention. The transaortic system for short-term circulatory support with pulsatile blood flow iVAC 2L consists of an external membrane pump, a 17Fr diameter catheter for reversed blood flow (intake cannula) with a patented two-way rotary valve. The pump has two chambers, one for blood and one for helium, separated by a flexible diaphragm. The blood chamber connects to the catheter and the air chamber connects to a standard IABP console. The bi-directional valve is located 72 mm from the aspiration tip of the catheter and determines the direction of blood flow. The catheter is advanced retrogradely through the common femoral artery so that the tip is located in the left ventricular (LV) cavity and the valve is in the ascending aorta. Synchronized with the cardiac cycle via ECG, the device draws blood from the LV into the pump chamber during systole and ejects blood from the pump into the ascending aorta during diastole. The primary composite outcome is all-cause mortality, including acute myocardial infarction, stroke and TIA during hospitalization and at Day 360 of follow-up, expressed as a percentage of total patients.
CONDITIONS
Official Title
Temporary MCS With the iVAC 2L Transaortic Device in High-risk PCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Multidisciplinary heart team consensus for high-risk PCI, defined as percutaneous intervention with high risk of circulatory collapse
- Signed informed consent to participate in the study
You will not qualify if you...
- Femoral artery diameter less than 6.0 mm
- Significant biventricular or right heart failure
- Thrombus in the left ventricle
- Presence of a mechanical aortic valve
- Aortic valve stenosis or calcification with orifice area 0.6 cm2 or less
- Moderate-to-severe aortic insufficiency (echocardiographic grade ≥+2)
- Severe peripheral arterial disease preventing iVAC 2L placement
- Combined cardiorespiratory failure
- Presence of atrial or ventricular septal defect
- Left ventricular rupture
- Cardiac tamponade
- Any other subtype of shock
- Known severe comorbidities affecting prognosis (chronic renal or liver failure, active malignancies)
- Recent major bleeding event within 3 months
- Recent stroke within 3 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
NMRCCardiologyRu
Moscow, Russia
Actively Recruiting
Research Team
O
Oleg Dorogun, MD
CONTACT
E
Eric Avetisyan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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