Mechanical left ventricular unloading with PulseCath iVAC2L during complex high-risk PCI

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

This is a multicenter interventional study in which patients selected by a multidisciplinary heart team for high-risk percutaneous coronary intervention receive mechanical circulatory support with the PulseCath iVAC2L device during the procedure. The iVAC2L is a pulsatile left ventricular pump that can deliver up to about 2 L/min of forward flow to maintain perfusion while balloons and stents are deployed. Eligible participants are hemodynamically stable adults with complex left main or equivalent disease and reduced left ventricular ejection fraction meeting prespecified thresholds, and they are monitored for peri-procedural hemodynamic stability and device-related complications. The study aims to determine whether LV unloading with the iVAC2L improves intra-procedural stability and safety compared with expected outcomes for similar high-risk procedures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years AND
* Multidisciplinary heart team consensus for high risk PCI +/- MCS AND
* Hemodynamically stable (SCAI A-B) AND
* LVEF \<30% OR LVEF \<35% with moderate MR OR LVEF \<40% with severe MR AND
* Complex left main disease (calcium modifying techniques deemed necessary OR 2-stent techniques, left dominant system) OR equivalent (ostial LAD and RCX) OR last remaining vessel (native).

Exclusion Criteria:

* Contraindications for Pulsecath IVAC2L:

  1. severe aortic regurgitation
  2. known presence of an LV thrombus (contrast echo/MRI)
  3. Mechanical aorta valve prosthesis
  4. severe aortic valve stenosis
  5. peripheral arterial disease that would preclude placement of the PulseCath iVAC2L device
* Cardiogenic shock defined as either SCAI CSWG stage C-E
* Patient is intubated and mechanically ventilated
* Stroke \<3 months
* Major bleeding event \<3 months
* History of bleeding diathesis or known coagulopathy (including heparin-induced thrombo-cytopenia), any recent GU or GI bleed, or will refuse blood transfusions.Renal replacement therapy
* Pregnancy, or suspected thereof.
* BMI \> 35
* Other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with study procedures.
* Subject belongs to a vulnerable population (defined as individuals with mental disability, persons in nursing homes, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent; vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces and persons kept in detention).

Where it's running

• Amsterdam University Medical Center
  Amsterdam, Netherlands Recruiting
• Zuyderland
  Geleen, Netherlands Recruiting
• University Medical Center Groningen
  Groningen, Netherlands Recruiting
• Leiden University Medical Center
  Leiden, Netherlands Recruiting
• Maastricht University Medical Center
  Maastricht, Netherlands Recruiting
• Radboud University Medical Center
  Nijmegen, Netherlands Recruiting

Study contacts

• Study coordinator: Alexander Nap, MD, PhD
• Email: a.nap@amsterdamumc.nl
• Phone: 0031 020 444 4445

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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.