NCT06625801 · ECRI bv
IVUS CHIP UPP Registry
What this study is about
The IVUS CHIP UPP Registry is a forward-looking, observational, conducted at multiple hospitals, single-treatment group$1 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.
View original scientific description
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.
Interventions
DEVICE
IVUS
Intravascular Ultrasound
Primary outcome measures
Target-vessel failure (TVF)
Time frame: 1 year after enrollment
TVF is defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-vessel revascularization
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Phoenix, Arizona
- Loma Linda, California
- Coral Gables, Florida
- Orlando, Florida
- Tampa, Florida
- Weston, Florida
- Atlanta, Georgia
- Chicago, Illinois
- Louisville, Kentucky
- Detroit, Michigan
- Duluth, Minnesota
- Jackson, Mississippi
And 3 more locations — see the full list below.
Collaborators
Boston Scientific Corporation, Cardialysis B.V.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 23, 2026 · Source of record for eligibility and locations