Status:
RECRUITING
Temporary MCS With the iVAC 2L Transaortic Device in High-risk PCI
Lead Sponsor:
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Conditions:
Ischemic Cardiovascular Disease
Multivessel Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 suppo...
Detailed Description
Although coronary artery bypass grafting (CABG) remains the standard treatment for patients with multivessel coronary artery disease, there is growing interest in performing protected percutaneous cor...
Eligibility Criteria
Inclusion
- Multidisciplinary heart team consensus for high-risk PCI. HR-PCI was defined as any percutaneous intervention for coronary disease involving an unusually high risk of periprocedural circulatory collapse.
- Signed Informed Consent to participate in the study
Exclusion
- Femoral artery diameter \< 6.0mm
- Significant biventricular or right heart failure
- Thrombus in the left ventricle
- Presence of a mechanical aortic valve
- Aortic valve stenosis/calcification (equivalent to an orifice area of 0.6 cm2 or less) or moderate-to-severe aortic insufficiency (echocardiographic assessment graded as ≥+2)
- Severe peripheral arterial disease precluding placement of the iVAC2L
- Combined cardiorespiratory failure
- Presence of an atrial or ventricular septal defect (including post infarct VSD)
- Left ventricular rupture
- Cardiac tamponade
- Presence of any other subtype of shock
- Known severe comorbidities independently affecting prognosis (chronic renal or liver failure, active malignancies etc.)
- Recent major bleeding event (\< 3 months)
- Recent stroke (\< 3 months)
Key Trial Info
Start Date :
February 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 17 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07149714
Start Date
February 17 2023
End Date
February 17 2029
Last Update
September 8 2025
Active Locations (1)
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1
NMRCCardiologyRu
Moscow, Russia