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New heart pump aims to make risky angioplasty safer

NCT ID NCT07149714

Disease control Sponsor: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a temporary heart pump called iVAC 2L in 100 patients undergoing high-risk angioplasty. The pump helps stabilize blood flow during the procedure. Researchers will track deaths, heart attacks, strokes, and other complications for up to a year to see if the device improves safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
iVAC 2L transaortic device (temporary mechanical heart pump)
What this could lead to
If successful, this device could provide a safer way to perform high-risk angioplasty in patients with severe coronary artery disease, potentially reducing deaths and major complications.
What could go wrong
This is an early-stage study with only 100 participants, so results may not apply to all patients. The device carries risks like bleeding, infection, or limb ischemia, and it is not yet proven to improve long-term outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

cardiogenic shock congestive heart failure coronary artery disorder heart failure myocardial ischemia Shock, Cardiogenic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute heart failure (AHF) Cardiogenic shock Chronic heart failure Coronary artery disease Ischemic cardiovascular disease Multivessel coronary artery disease Percutaneous coronary intervention

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • NMRCCardiologyRu

    RECRUITING

    Moscow, Russia

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