Ischemic Cardiovascular DiseasePOTOKNCT07149714
Temporary MCS With the iVAC 2L Transaortic Device in High-risk PCI
A study testing iVAC 2L in people with Ischemic Cardiovascular Disease and Multivessel Coronary Artery Disease, run by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Cardiovascular Disease, Multivessel Coronary Artery Disease, Coronary Artery Disease
- What is being tested?
- iVAC 2L
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 17 Feb 2023to 17 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
NMRCCardiologyRu
Moscow
Lavrentii Dulaev, 4240030 ext. +7985, la.dulaev@mail.ru
Nikita Grishin, 5799185 ext. +7977, n.s.grishin@mail.ru
About this study
Official title: Temporary Mechanical Circulatory Support With the iVAC 2L Transaortic Device in High-risk Percutaneous Coronary Intervention
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.
Read more
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.
Read the 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
- Being tested
- iVAC 2L
- Keywords
- Mechanical circulatory support, High-Risk Percutaneous Coronary Intervention, Coronary artery disease
- Medical subject headings
- Coronary Artery Disease, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iVAC 2LDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: iVAC 2L |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At day 7 after PCI or at discharge, if earlier. At day 360 of follow-up.
Secondary outcomes (20)
Major vascular complications
Complications include development of limb ischemia after PCI, bleeding in access site, development of arteriovenous fistula and infectious access site complications, as per VARC-2 definitions.
Measured: 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
According to the Fourth Universal Definition of Myocardial Infarction (ESC, 2018)
Measured: During the 360-day follow-up period
Angiographic failure
Angiographic failure/procedural failure, as defined in the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention Circulation: post-procedure TIMI flow < grade III, residual stenosis (>50% post-balloon or > 10% post stenting), or presence of thrombus, side branch loss or flow limiting dissection. It is a binary outcome (yes/no answer).
Measured: Immediately after PCI.
Incidence of intraprocedural complications
Including life-threatening ventricular arrhythmias, cardiac arrest, and progression of cardiogenic shock (as per SCAI classification)
Measured: From the beginning of the PCI until its conclusion, the PCI is estimated to be from 40 to 270 minutes.
Left ventricular myocardial function
Ejection fraction, measured in percentages; based on trans-thoracic echocardiographic assessment
Measured: At day 7 after PCI or at discharge, if earlier.
Incidence of acute kidney injury
Assessed via changes in serum creatinine and/or urine output, according to KDIGO 2012 criteria
Measured: At day 7 after PCI or at discharge, if earlier.
Angiographic characteristics
SYNTAX score (to estimate the complexity of coronary artery disease, higher score is associated with poor clinical outcomes) before and after the procedure, anatomical characteristics of the coronary arteries (three-vessel, unprotected left main, last remaining vessel and bifurcational lesions), the use of intravascular imaging (ex. IVUS).
Measured: From the beginning of the PCI until its conclusion. The PCI is estimated to be from 40 to 270 minutes.
Number of Participants with ventricular arrhythmias
VT requiring cardioversion and/or need for CPR. Binary outcome, VF during hospitalization.
Measured: From the beginning of the PCI until its conclusion, the PCI is estimated to be from 40 to 270 minutes. At day 7 after PCI or at discharge, if earlier.
Number of participants with progression of cardiogenic shock
As defined by SCAI-CSWG in 2022
Measured: From the beginning of the PCI until its conclusion, the PCI is estimated to be from 40 to 270 minutes. At day 7 after PCI or at discharge, if earlier.
Number of participants with major bleeding
Major bleeding (BARC 3 to 5) after PCI, according to the BARC Bleeding Classification 2011.
Measured: At day 7 after PCI or at discharge, if earlier.
Number of participants with acute myocardial infarction
According to the Fourth Universal Definition of Acute Myocardial Infarction (ESC, 2018). 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).
Measured: At day 7 after PCI or at discharge, if earlier. At day 360 of follow-up.
Number of participants with stroke or transient ischemic attack
As per VARC 2 definitions 2013. 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).
Measured: At day 7 after PCI or at discharge, if earlier. At day 360 of follow-up.
Repeat revascularization
As per ARC definition 2007. 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).
Measured: At day 7 after PCI or at discharge, if earlier. At day 360 of follow-up.
Intraprocedual device-related characteristics
Implantation failure, device operating mode (internal or ECG synchronized), duration of device runtime (measured in minutes), device dislocation, use of other MCS
Measured: From the beginning of the PCI until its conclusion, the PCI is estimated to be from 40 to 270 minutes.
Change in Left ventricular ejection fraction
Numerical continuous variable. Change in LVEF measured by trans-thoracic echocardiography at baseline and discharge. Measured in percentages.
Measured: From baseline (before the PCI) to the moment of discharge, typically on the 5-7 day after PCI.
Severity of aortic valve regurgitation
Based on trans-thoracic echocardiographic assessment as per European Association of Echocardiography guidelines.
Measured: At baseline (before the PCI).
Severity of mitral valve stenosis
Based on trans-thoracic echocardiographic assessment as per European Association of Echocardiography guidelines.
Measured: At baseline (before the PCI).
Severity of triscupid valve regurgitation
Based on trans-thoracic echocardiographic assessment as per European Association of Echocardiography guidelines.
Measured: At baseline (before the PCI).
Severity of aortic valve stenosis
Based on trans-thoracic echocardiographic assessment as per European Association of Echocardiography guidelines.
Measured: At baseline (before the PCI).
Severity of mitral valve regurgitation
Based on trans-thoracic echocardiographic assessment as per European Association of Echocardiography guidelines.
Measured: At baseline (before the PCI).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start17 Feb 2023
- Primary completion17 Feb 2028 (estimated)
- Study completion17 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ischemic Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dmitry Pevzner, National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
- Investigators
- Dmitry Pevzner, MD, Principal investigator, National Medical Research Center for Cardiology, Ministry of Health of Russian FederationEvgeniy Merkulov, MD, Principal investigator, National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149714
- Sponsor's protocol ID
- 2023-32-1
- Acronym
- POTOK
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39336843Samol 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.
PubMed 35597491Ameloot 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.
PubMed 30741638Bastos 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.
PubMed 31934785den 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.
PubMed 28216471Bastos 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.
PubMed 35331637
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporary Mechanical Circulatory Support With the iVAC 2L Transaortic Device in High-risk Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT07149714
- Acronym / sponsor ID
- POTOK / 2023-32-1
- Conditions
- Ischemic Cardiovascular Disease, Multivessel Coronary Artery Disease, Coronary Artery Disease, Cardiogenic Shock, Acute Heart Failure (AHF), Chronic Heart Failure
- Keywords
- Mechanical circulatory support, High-Risk Percutaneous Coronary Intervention, Coronary artery disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Medical Research Center for Cardiology, Ministry of Health of Russian FederationOther government
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 17 Feb 2028 (estimated)
- Study completion
- 17 Feb 2029 (estimated)
- First posted
- 2 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Safety and clinical efficacy of temporary MCS with the iVAC 2L transaortic device in high-risk PCI | Experimental | Device: iVAC 2L100 pts with coronary artery disease with indications for High-Risk Percutaneous Coronary Intervention and no contradictions for the placement of the iVAC2L. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iVAC 2LThe 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. | Device | Safety and clinical efficacy of temporary MCS with the iVAC 2L transaortic device in high-risk PCI |
Primary outcome
All-cause mortality
Time frame: At day 7 after PCI or at discharge, if earlier. At day 360 of follow-up.
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).
20 secondary outcomes
Major vascular complications
Time frame: 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
Time frame: During the 360-day follow-up period
Angiographic failure
Time frame: Immediately after PCI.
Incidence of intraprocedural complications
Time frame: From the beginning of the PCI until its conclusion, the PCI is estimated to be from 40 to 270 minutes.
Left ventricular myocardial function
Time frame: At day 7 after PCI or at discharge, if earlier.
Incidence of acute kidney injury
Time frame: At day 7 after PCI or at discharge, if earlier.
Angiographic characteristics
Time frame: From the beginning of the PCI until its conclusion. The PCI is estimated to be from 40 to 270 minutes.
Number of Participants with ventricular arrhythmias
Time frame: From the beginning of the PCI until its conclusion, the PCI is estimated to be from 40 to 270 minutes. At day 7 after PCI or at discharge, if earlier.
Number of participants with progression of cardiogenic shock
Time frame: From the beginning of the PCI until its conclusion, the PCI is estimated to be from 40 to 270 minutes. At day 7 after PCI or at discharge, if earlier.
Number of participants with major bleeding
Time frame: At day 7 after PCI or at discharge, if earlier.
Number of participants with acute myocardial infarction
Time frame: At day 7 after PCI or at discharge, if earlier. At day 360 of follow-up.
Number of participants with stroke or transient ischemic attack
Time frame: At day 7 after PCI or at discharge, if earlier. At day 360 of follow-up.
Repeat revascularization
Time frame: At day 7 after PCI or at discharge, if earlier. At day 360 of follow-up.
Intraprocedual device-related characteristics
Time frame: From the beginning of the PCI until its conclusion, the PCI is estimated to be from 40 to 270 minutes.
Change in Left ventricular ejection fraction
Time frame: From baseline (before the PCI) to the moment of discharge, typically on the 5-7 day after PCI.
Severity of aortic valve regurgitation
Time frame: At baseline (before the PCI).
Severity of mitral valve stenosis
Time frame: At baseline (before the PCI).
Severity of triscupid valve regurgitation
Time frame: At baseline (before the PCI).
Severity of aortic valve stenosis
Time frame: At baseline (before the PCI).
Severity of mitral valve regurgitation
Time frame: At baseline (before the PCI).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Background: PubMed 39336843Bulum 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.
- Background: PubMed 35597491Samol 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.
- Background: PubMed 30741638Ameloot 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.
- Background: PubMed 31934785Bastos 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.
- Background: PubMed 28216471den 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.
- Background: PubMed 35331637Bastos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dmitry Pevzner, MD principal investigator
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Evgeniy Merkulov, MD principal investigator
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iVAC 2L in people with Ischemic Cardiovascular Disease and Multivessel Coronary Artery Disease, run by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oleg Dorogun, MD (7642159 ext. +7919, oleg.dorogun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: At day 7 after PCI or at discharge, if earlier. At day 360 of follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07149714, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.