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

NCT07149714 | Recruiting

• 1 other identifier: 2023-32-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Mechanical circulatory support; High-Risk Percutaneous Coronary Intervention; Coronary artery disease

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  Constitutes one of the components of the MACCE composite endpoint: all-cause mortality, acute myocardial infarction, stroke or transient ischemic attack (TIA), and repeat revascularization (PCI or CABG).

  At day 7 after PCI or at discharge, if earlier. At day 360 of follow-up.

Secondary Outcomes (20)

• Major vascular complications

  From the beginning of the PCI until its conclusion, the PCI is estimated to be from 40 to 270 minutes.

• Incidence of recurrent myocardial infarction or reinfarction

  During the 360-day follow-up period

• Angiographic failure

  Immediately after PCI.

• Incidence of intraprocedural complications

  From the beginning of the PCI until its conclusion, the PCI is estimated to be from 40 to 270 minutes.

• Left ventricular myocardial function

  At day 7 after PCI or at discharge, if earlier.

Study Arms (1)

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

EXPERIMENTAL

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

Device: iVAC 2L

Interventions

iVAC 2L 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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

NMRCCardiologyRu

Moscow, Russia

RECRUITING

Related Publications (6)

• 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.

  PMID: 39336843 BACKGROUND

• 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.

  PMID: 35597491 BACKGROUND

• 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.

  PMID: 30741638 BACKGROUND

• 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.

  PMID: 31934785 BACKGROUND

• 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.

  PMID: 28216471 BACKGROUND

• 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.

  PMID: 35331637 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Dmitry Pevzner, MD

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

  PRINCIPAL INVESTIGATOR

• Evgeniy Merkulov, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oleg Dorogun, MD

CONTACT

7642159; oleg.dorogun@gmail.com

Eric Avetisyan, MD

CONTACT

4374050; avetisyan.erik@inbox.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Emergency Cardiology Department

Model Details: 100 pts with coronary artery disease with indications for High-Risk Percutaneous Coronary Intervention and no contradictions for the placement of the iVAC2L will be enrolled. The risk of PCI 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.). Pts participating in the clinical trial are expected to remain hospitalized for approximately 7-14 days and will be followed for 360 days (with an acceptable range of 350-370 days) after the intervention or until the occurrence of the primary endpoint.

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: September 2, 2025
• Study Start: February 17, 2023
• Primary Completion (Estimated): February 17, 2028
• Study Completion (Estimated): February 17, 2029
• Last Updated: September 8, 2025

Record last verified: 2025-08

Locations

RU (1)