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New treatment option for High-risk PCI
Official title Use of Mechanical Left ventricuLar Unloading in Complex Higher-risk Indicated Procedures
ClinicalTrials.gov ID: NCT07380217
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
You likely can't join 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
See the full eligibility 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).
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
- Geleen, Netherlands
- Groningen, Netherlands
- Leiden, Netherlands
- Maastricht, Netherlands
- Nijmegen, Netherlands
- The Hague, Netherlands
- Utrecht, Netherlands
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands; Geleen, Netherlands; Groningen, Netherlands; Leiden, Netherlands; Maastricht, Netherlands; Nijmegen, Netherlands and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.