Temporary heart support with the iVAC 2L device during high-risk coronary procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Aspirin 50 mg vs 100 mg with a P2Y12 inhibitor after PCI

  This trial tests whether a 50 mg daily aspirin dose, when used with a P2Y12 inhibitor after PCI, works as well as 100 mg with similar safety for people staying on DAPT for 12 months.

  Recruiting Jilin University · Changchun, Jilin · NCT07846462

• Long-term P2Y12 inhibitor monotherapy and blood clotting after angioplasty

  This trial will test whether specific P2Y12 drugs and reduced doses given alone keep platelet activity in a safe therapeutic range for people who completed initial dual antiplatelet therapy after PCI.

  Recruiting Phase 3 Cardiocentro Ticino · Lugano, Ch/ti · NCT07582835

• Prolonged nasogastric ketone infusion for decompensated heart failure

  This will test whether a continuous nasogastric infusion of a ketone (D‑beta‑hydroxybutyrate) can safely reach target blood levels in adults with severely reduced ejection fraction admitted for acute decompensated heart failure or cardiogenic shock.

  Recruiting Phase 4 Institute for Clinical and Experimental Medicine · Prague, Prague · NCT07527156

• Multimodal profiling of adults hospitalized with acute heart failure and cardiogenic shock

  This project will test whether combining routine hospital data with extra blood and urine samples can help doctors identify types of cardiogenic shock and predict 30-day outcomes in adults hospitalized with acute heart failure.

  Recruiting at 4 sites University Heart Center Freiburg - Bad Krozingen · Bad Krozingen and 3 other locations · NCT07515508

• What affects bleeding control and how long you need to lie flat after femoral arterial sheath removal

  We will see if patient and procedure factors can predict how long ICU patients need compression and bed rest after femoral arterial sheath removal to prevent bleeding and hematoma.

  Recruiting National Taiwan University Hospital · Taipei · NCT07469397

• Doctors' and patients' preferences for PCI implantation devices

  This questionnaire tests what patients who have had PCI and the doctors who treat them prefer between drug-eluting stents and drug-coated balloons.

  Recruiting Xijing Hospital · Xi'an, Shannxi · NCT07378163

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.