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

NCT ID: NCT07149714

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-17
• Study Completion Date: 2029-02-17

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 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.

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 coronary intervention (PCI) in high-risk patients. Protected PCI involves the use of temporary mechanical circulatory support (MCS) devices during and shortly after the procedure to maintain hemodynamic stability and reduce the risk of complications such as acute left ventricular failure. This approach offers a safer alternative to open-heart surgery in patients for whom CABG poses significant operative risks. 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.

On admission patients will undergo ECG, echocardiography, routine blood tests including complete blood count and basic metabolic panel. After then the patient's risk will be assessed by the institution's heart team (presence of severe coronary artery disease, acute coronary syndrome, other comorbidities including renal disease, diabetes mellitus, chronic and acute heart failure etc.).

For placement of the iVAC 2L transaortic device the patient will be transported to the X-ray operating room. The transaortic system for short-term circulatory support with pulsatile blood flow that consists of three main components: an external membrane pump, a 17Fr diameter catheter for reversed blood flow (intake cannula) and 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. Advantages of the iVAC 2L include a minimally invasive implantation technique, pulsatile flow that may be more physiologic compared to continuous flow devices, and a lower risk of hemolysis and vascular complications compared to other MCS devices.

After surgery further monitoring of the patient will be carried out in the intensive care unit. During hospitalization treatment and diagnostic evaluation of patients will be done according to current clinical practice guidelines.

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

Ischemic Cardiovascular Disease; Multivessel Coronary Artery Disease; Coronary Artery Disease; Cardiogenic Shock; Acute Heart Failure (AHF); Chronic Heart Failure; Percutaneous Coronary Intervention

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Safety and clinical efficacy of temporary MCS with the iVAC 2L transaortic device in high-risk PCI

100 pts with coronary artery disease with indications for High-Risk Percutaneous Coronary Intervention and no contradictions for the placement of the iVAC2L.

Group Type: EXPERIMENTAL

iVAC 2L

Intervention Type: DEVICE

The goal of this study is to investigate the safety and clinical efficacy of temporary mechanical support system with the iVAC 2L transaortic device in high-risk percutaneous coronary intervention (PCI) in Russia and Belarus. The POTOK trial will include patients with indications for elective, urgent and emergency PCI.

Interventions

iVAC 2L

The goal of this study is to investigate the safety and clinical efficacy of temporary mechanical support system with the iVAC 2L transaortic device in high-risk percutaneous coronary intervention (PCI) in Russia and Belarus. The POTOK trial will include patients with indications for elective, urgent and emergency PCI.

Intervention Type: DEVICE

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dmitry Pevzner

Head of the Emergency Cardiology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dmitry Pevzner, MD

Role: PRINCIPAL_INVESTIGATOR

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

Evgeniy Merkulov, MD

Role: PRINCIPAL_INVESTIGATOR

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

Locations

NMRCCardiologyRu

Moscow, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Oleg Dorogun, MD

Role: CONTACT

oleg.dorogun@gmail.com

7642159 ext. +7919

Eric Avetisyan, MD

Role: CONTACT

avetisyan.erik@inbox.ru

4374050 ext. +7910

Facility Contacts

Lavrentii Dulaev

Role: primary

la.dulaev@mail.ru

4240030 ext. +7985

Nikita Grishin

Role: backup

n.s.grishin@mail.ru

5799185 ext. +7977

References

Bulum J, Bastos MB, Hlinomaz O, Malkin O, Pawlowski T, Dragula M, Gil R. Pulsatile Left Ventricular Assistance in High-Risk Percutaneous Coronary Interventions: Short-Term Outcomes. J Clin Med. 2024 Sep 10;13(18):5357. doi: 10.3390/jcm13185357.

Reference Type: BACKGROUND

PMID: 39336843 (View on PubMed)

Samol A, Wiemer M, Kaese S. Comparison of a pulsatile and a continuous flow left ventricular assist device in high-risk PCI. Int J Cardiol. 2022 Aug 1;360:7-12. doi: 10.1016/j.ijcard.2022.05.038. Epub 2022 May 18.

Reference Type: BACKGROUND

PMID: 35597491 (View on PubMed)

Ameloot K, B Bastos M, Daemen J, Schreuder J, Boersma E, Zijlstra F, Van Mieghem NM. New-generation mechanical circulatory support during high-risk PCI: a cross-sectional analysis. EuroIntervention. 2019 Aug 29;15(5):427-433. doi: 10.4244/EIJ-D-18-01126.

Reference Type: BACKGROUND

PMID: 30741638 (View on PubMed)

Bastos MB, van Wiechen MP, Van Mieghem NM. PulseCath iVAC2L: next-generation pulsatile mechanical circulatory support. Future Cardiol. 2020 Mar;16(2):103-112. doi: 10.2217/fca-2019-0060. Epub 2020 Jan 14.

Reference Type: BACKGROUND

PMID: 31934785 (View on PubMed)

den Uil CA, Daemen J, Lenzen MJ, Maugenest AM, Joziasse L, van Geuns RJ, Van Mieghem NM. Pulsatile iVAC 2L circulatory support in high-risk percutaneous coronary intervention. EuroIntervention. 2017 Feb 20;12(14):1689-1696. doi: 10.4244/EIJ-D-16-00371.

Reference Type: BACKGROUND

PMID: 28216471 (View on PubMed)

Bastos MB, McConkey H, Malkin O, den Uil C, Daemen J, Patterson T, Wolff Q, Kardys I, Schreuder J, Lenzen M, Zijlstra F, Redwood S, Van Mieghem NM. Effect of Next Generation Pulsatile Mechanical Circulatory Support on Cardiac Mechanics: The PULSE Trial. Cardiovasc Revasc Med. 2022 Sep;42:133-142. doi: 10.1016/j.carrev.2022.03.013. Epub 2022 Mar 14.

Reference Type: BACKGROUND

PMID: 35331637 (View on PubMed)

Other Identifiers

2023-32-1

Identifier Type: -

Identifier Source: org_study_id