[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"coronary-artery-disease-risk-high\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:coronary-artery-disease-risk-high":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100622176","use-of-mechanical-left-ventricular-unloading-in-complex-higher-risk-indicated-procedures-100622176",false,"NCT07380217","Use of Mechanical Left ventricuLar Unloading in Complex Higher-risk Indicated Procedures","Use of mechaNical Left ventricuLar unlOADing in Complex Higher-risk Indicated Procedures","UNLOAD-CHIP","Inclusion Criteria:\n\n* Age ≥18 years AND\n* Multidisciplinary heart team consensus for high risk PCI +\u002F- MCS AND\n* Hemodynamically stable (SCAI A-B) AND\n* LVEF \\\u003C30% OR LVEF \\\u003C35% with moderate MR OR LVEF \\\u003C40% with severe MR AND\n* 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).\n\nExclusion Criteria:\n\n* Contraindications for Pulsecath IVAC2L:\n\n  1. severe aortic regurgitation\n  2. known presence of an LV thrombus (contrast echo\u002FMRI)\n  3. Mechanical aorta valve prosthesis\n  4. severe aortic valve stenosis\n  5. peripheral arterial disease that would preclude placement of the PulseCath iVAC2L device\n* Cardiogenic shock defined as either SCAI CSWG stage C-E\n* Patient is intubated and mechanically ventilated\n* Stroke \\\u003C3 months\n* Major bleeding event \\\u003C3 months\n* 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\n* Pregnancy, or suspected thereof.\n* BMI \\> 35\n* Other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and\u002For to comply with study procedures.\n* 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).","ALL","18 Years",{"count":20,"type":21},98,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.\n\nDuring 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.\n\nTo 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.\n\nThis study aims to investigate whether mechanical circulatory support, specifically with the Pulsecath iVAC2L, leads to improved outcomes for patients undergoing high-risk PCI.",[27,28],"High-risk PCI","Coronary Artery Disease Risk High",[27,30,31,32,33,34],"CHIP","Mechanical Circulatory Support","Pulsecath iVAC2L","Pulsecath","iVAC2L","RECRUITING","2026-01-26",{"date":38,"type":39},"2026-02-02","ACTUAL",{"date":41,"type":39},"2024-01-25",{"date":43,"type":21},"2027-03-01",{"name":45,"class":46},"Amsterdam UMC, location VUmc","OTHER",8,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":57,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100564178","ivus-chip-upp-registry-100564178","NCT06625801","IVUS CHIP UPP Registry","Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures in Underrepresented Patient Populations Registry","Inclusion Criteria:\n\n1. The patient must be ≥18 years of age and self-identify within a US census-defined minority\n2. Patients with an indication for PCI of at least one lesion satisfying any of the following criteria:\n\n   1. Angiographic heavy calcification\n   2. Ostial lesions\n   3. True bifurcation lesions involving side-branches \\>2.5mm\n   4. Left main lesions\n   5. Chronic total occlusion\n   6. In-stent restenosis\n   7. Long-lesions (estimated stent length \\> 28mm) OR Patient with an indication for PCI for any lesion and in need for elective mechanical circulatory support assisted PCI\n3. Presenting with silent ischemia, stable angina, unstable angina or non-ST-elevation acute coronary syndrome (NSTE-ACS)\n4. All lesions must be suitable for treatment with FDA-approved contemporary generation drug eluting stents or drug-coated balloons\n5. The patient is willing and able to cooperate with registry procedures and follow-up until registry completion\n6. Subject is able to confirm understanding of risks, benefits and treatment alternatives and he\u002Fshe (or an authorized legal representative) provides informed consent prior to any protocol-related procedure, as approved by the appropriate IRB\n\nExclusion Criteria:\n\n1. ST-elevation myocardial infarction or cardiogenic shock within prior 7 days\n2. Known untreated severe valvular heart disease\n3. Contraindication on the use of IVUS (i.e. extreme vessel tortuosity)\n4. Requiring PCI in a diseased aorto-coronary bypass\n5. Known contraindication or hypersensitivity to anticoagulants\n6. Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12 inhibitors\n7. Non-cardiac co-morbidities with a life expectancy less than 1 year\n8. A patients that is currently participating in a clinical trial that has not yet reached its primary endpoint cannot be included in this registry. A patient may only be enrolled in this registry once.",{"count":56,"type":21},1010,"24 Months","OBSERVATIONAL","The IVUS CHIP UPP Registry is a prospective, observational, multicenter, single-arm registry. A total of 1010 patients with complex coronary lesions will be enrolled in up to 2 years, with at least 500 men and women. All patients will be treated with IVUS-guided PCI.",[61,28,62],"Coronary Artery Disease","Complex Coronary Artery Disease",[64,65,30,66],"PCI","intravascular ultrasound","ivus-guidance","NOT_YET_RECRUITING","2025-08-25",{"date":70,"type":39},"2025-09-02",{"date":72,"type":21},"2025-09",{"date":74,"type":21},"2029-03",{"name":76,"class":77},"ECRI bv","INDUSTRY"]