Temporary heart support with the iVAC 2L device during high-risk coronary procedures
Temporary Mechanical Circulatory Support With the iVAC 2L Transaortic Device in High-risk Percutaneous Coronary Intervention
NA · National Medical Research Center for Cardiology, Ministry of Health of Russian Federation · NCT07149714
This trial will try the iVAC 2L temporary heart‑support device during high‑risk PCI to help people with severe coronary artery disease stay hemodynamically stable through the procedure.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Medical Research Center for Cardiology, Ministry of Health of Russian Federation (other gov) |
| Locations | 1 site (Moscow) |
| Trial ID | NCT07149714 on ClinicalTrials.gov |
What this trial studies
Patients judged by a multidisciplinary heart team to need protected high‑risk percutaneous coronary intervention will be offered temporary mechanical circulatory support with the iVAC 2L transaortic device. The device uses a 17Fr catheter and an external pulsatile pump connected to an IABP console to provide short‑term circulatory support during and shortly after PCI. Participants undergo standard preprocedural testing (ECG, echocardiography, labs) and are monitored in the X‑ray operating room for procedural safety and clinical outcomes. The study focuses on device safety, feasibility of placement, and clinical endpoints related to hemodynamic stability and complications.
Who should consider this trial
Good fit: Ideal candidates are patients selected by a heart team for high‑risk PCI (multivessel or complex coronary disease) who consent to the procedure and have suitable vascular anatomy (femoral artery ≥6.0 mm) and no exclusionary cardiac or vascular conditions.
Not a fit: Patients with very small femoral arteries, severe biventricular or right heart failure, left ventricular thrombus, mechanical aortic valves, significant aortic valve disease, severe peripheral arterial disease, combined cardiorespiratory failure, or other major comorbidities are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the iVAC 2L could reduce procedure‑related hemodynamic collapse and improve short‑ and possibly long‑term outcomes for patients undergoing high‑risk PCI.
How similar studies have performed: Pulsatile transaortic support with the iVAC 2L is relatively novel with limited published data, while other temporary MCS devices (eg, Impella, ECMO) have produced mixed but informative results in protected PCI settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Moscow
- NMRCCardiologyRu — Moscow, Russia (RECRUITING)
Study contacts
- Principal investigator: Dmitry Pevzner, MD — National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
- Study coordinator: Oleg Dorogun, MD
- Email: oleg.dorogun@gmail.com
- Phone: 7642159
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ischemic Cardiovascular Disease, Multivessel Coronary Artery Disease, Coronary Artery Disease, Cardiogenic Shock, Acute Heart Failure, Chronic Heart Failure, Percutaneous Coronary Intervention, Mechanical circulatory support