Use of Mechanical Left ventricuLar Unloading in Complex Higher-risk Indicated Procedures

NCT07380217 | Recruiting DMC

• 2 other identifiers: NL83524.018.23NL-OMON53381
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 8

Brief Summary

If there is a narrowing or blockage in the coronary arteries of the heart, the cardiologist may choose to treat this blockage. This is called percutaneous coronary intervention (PCI), which involves both balloon angioplasty and the placement of a stent. PCI is a commonly performed and safe procedure. However, in your case, the procedure is more complicated than usual due to the location and nature of the narrowing, the required technique for the intervention, and the fact that your heart function is reduced. As a result, your PCI will carry a higher risk than usual. During the procedure, balloons are inflated to clear the blockage, and a stent is placed to keep the artery open. This temporarily reduces or even stops the blood and oxygen supply to a large portion of the heart. This moment presents a higher risk for complications, such as low blood pressure or cardiac arrest. As a result, the heart may not pump blood effectively throughout the body, which can lead to oxygen deprivation in other organs. To help the heart in this situation, it is possible to insert a mechanical heart pump during the procedure. This form of support is introduced via an artery in the groin into your left ventricle. The pump helps the heart function and may improve the circulation to the body's organs. On the other hand, the placement of the pump increases the chance of complications. Therefore, there are both potential benefits and risks. It is currently unclear whether PCI with the temporary pump can be performed more safely than without it. This study aims to investigate whether mechanical circulatory support, specifically with the Pulsecath iVAC2L, leads to improved outcomes for patients undergoing high-risk PCI.

Conditions

High-risk PCI; Coronary Artery Disease Risk High

Keywords

High-risk PCI; CHIP; Mechanical Circulatory Support; Pulsecath iVAC2L; Pulsecath; iVAC2L

Outcome Measures

Primary Outcomes (1)

• Combined endpoint: - All-cause death - Cardiogenic shock (SCAI stage C-E) - (Need for) renal replacement therapy - (Need for) mechanical ventilation - Ventricular arrhythmias leading to loss of cardiac output requiring CPR

  30 days

Secondary Outcomes (16)

• PCWP (Δ max)

  Periprocedural

• LVEDP (Δ max)

  Periprocedural

• CO / CI / CPO (Δ max)

  Periprocedural

• SvO2 (Δ max)

  Periprocedural

• Drop in arterial pressure (MAP <60 OR SBP <90) for >10 minutes

  Periprocedural

Other Outcomes (4)

• Major vascular events

  30 days

• Limb ischemia

  30 days

• Bleeding events (BARC 3 and 5)

  30 days

Study Arms (2)

Standard-of-Care (without MCS)

NO INTERVENTION

Patients will undergo high-risk PCI without upfront use of MCS

Pulsecath iVAC2L (with MCS)

EXPERIMENTAL

Patients will undergo high-risk PCI with upfront use of the Pulsecath iVAC2L (MCS)

Device: Mechanical circulatory support with the Pulsecath iVAC2L device

Interventions

Mechanical circulatory support with the Pulsecath iVAC2L device DEVICE

The Pulsecath iVAC2L is a pulsatile pump, placed in the left ventricle, that ejects blood into the ascending aorta at a flow up to 2L/min. Theoretically, pulsatility maintains the physiological vascular responses and endothelial function at the level of the -systemic and -micro circulation and might offer benefit when compared to continues flow devices such as Impella. In contrast, IABP (which also offers pulsatile support), lacks the possibility of active unloading. Therefore, the combination of those features in the PulseCath iVAC2L is unique.

Pulsecath iVAC2L (with MCS)

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• Contraindications for Pulsecath IVAC2L:
• severe aortic regurgitation
• known presence of an LV thrombus (contrast echo/MRI)
• Mechanical aorta valve prosthesis
• severe aortic valve stenosis
• 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).

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Pulsecath BV.: collaborator

Study Sites (8)

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

Haaglanden Medical Center

The Hague, Netherlands

RECRUITING

University Medical Center Utrecht

Utrecht, Netherlands

RECRUITING

Central Study Contacts

Alexander Nap, MD, PhD

CONTACT

0031 020 444 4445; a.nap@amsterdamumc.nl

Tijmen H. Ris, MD

CONTACT

0031 020 444 4445; t.h.ris@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: February 2, 2026
• Study Start: January 25, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

NL (8)