Overview
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.
Description
Objective is to describe in a United States population the clinical efficacy and safety of an IVUS-guided approach in patients who self-identify within a census-defined minority undergoing PCI of complex coronary lesions, as well as clinical outcomes up to 2 years.
Eligibility
Inclusion Criteria:
- The patient must be ≥18 years of age and self-identify within a US census-defined minority
- Patients with an indication for PCI of at least one lesion satisfying any of the following criteria:
- Angiographic heavy calcification
- Ostial lesions
- True bifurcation lesions involving side-branches \>2.5mm
- Left main lesions
- Chronic total occlusion
- In-stent restenosis
- 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
- Presenting with silent ischemia, stable angina, unstable angina or non-ST-elevation acute coronary syndrome (NSTE-ACS)
- All lesions must be suitable for treatment with FDA-approved contemporary generation drug eluting stents or drug-coated balloons
- The patient is willing and able to cooperate with registry procedures and follow-up until registry completion
- 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:
- ST-elevation myocardial infarction or cardiogenic shock within prior 7 days
- Known untreated severe valvular heart disease
- Contraindication on the use of IVUS (i.e. extreme vessel tortuosity)
- Requiring PCI in a diseased aorto-coronary bypass
- Known contraindication or hypersensitivity to anticoagulants
- Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12 inhibitors
- Non-cardiac co-morbidities with a life expectancy less than 1 year
- 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.
