IVUS CHIP UPP Registry

European Cardiovascular Research Institute (ECRI)

Status: Not yet enrolling

Conditions: Coronary Artery Disease; Coronary Artery Disease Risk High; Complex Coronary Artery Disease

Treatments: Device: IVUS

Study type: Observational

Funder types: Industry

Identifiers

NCT06625801

ECRI-14-US

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,010 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The patient must be ≥18 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.

Trial design

1,010 participants in 1 patient group

IVUS-guided PCI in patients traditionally underrepresented in clinical trials

Description:

Patients undergoing IVUS-guided PCI for complex coronary artery disease who self-identify within a census-defined minority in the United States

Treatment:

Device: IVUS