🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Temporary MCS With the iVAC 2L Transaortic Device in High-risk PCI

RecruitingNAAges 18 Years - anyAllNational Medical Research Center for Cardiology, …
NCT07149714 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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)
💊

What it tests

  • iVAC 2L
📍

Where

1 site
NMRCCardiologyRu
Moscow, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy