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โ† Trials
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IVUS CHIP UPP Registry

Recruitingn/aAges 18 Years - anyAllECRI bv
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. The patient must be โ‰ฅ18 years of age and self-identify within a US census-defined minority 2. Patients with an indication for PCI of at least one lesion satisfying any of the following criteria: 1. Angiographic heavy calcification 2. Ostial lesions 3. True bifurcation lesions involving side-branches \>2.5mm 4. Left main lesions 5. Chronic total occlusion 6. In-stent restenosis 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 3. Presenting with silent ischemia, stable angina, unstable angina or non-ST-elevation acute coronary syndrome (NSTE-ACS) 4. All lesions must be suitable for treatment with FDA-approved contemporary generation drug eluting stents or drug-coated balloons 5. The patient is willing and able to cooperate with registry procedures and follow-up until registry completion 6. Subject is able to confirm understanding of risks, benefits and treatment alternatives and he/she (or an authorized legal representative) provides informed consent prior to any protocol-related procedure, as approved by the appropriate IRB Exclusion Criteria: 1. ST-elevation myocardial infarction or cardiogenic shock within prior 7 days 2. Known untreated severe valvular heart disease 3. Contraindication on the use of IVUS (i.e. extreme vessel tortuosity) 4. Requiring PCI in a diseased aorto-coronary bypass 5. Known contraindication or hypersensitivity to anticoagulants 6. Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12 inhibitors 7. Non-cardiac co-morbidities with a life expectancy less than 1 year 8. 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.
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What it tests

  • IVUS
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Where

18 sites
Banner Health
Phoenix, United States
Loma Linda University Health
Loma Linda, United States
Baptist Health
Coral Gables, United States
Advent Health
Orlando, United States
Advent Health
Tampa, United States
Cleveland Clinic Florida
Weston, United States
Emory University Hospital Midtown
Atlanta, United States
Piedmont Heart Institute
Atlanta, United States

โ€ฆand 10 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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