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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
| Cardialysis B.V. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVUS-guided PCI in patients traditionally underrepresented in clinical trials | Patients undergoing IVUS-guided PCI for complex coronary artery disease who self-identify within a census-defined minority in the United States |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVUS | Device | Intravascular Ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target-vessel failure (TVF) | TVF is defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-vessel revascularization | 1 year after enrollment |
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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:
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:
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Patients self-identified within a US census-defined minority with indication for IVUS-guided PCI of complex coronary lesions are consented for entering into the registry.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chantal Bakker | Contact | 31+102062828 | CBakker@cardialysis.nl | |
| Ernest Spitzer, MD | Contact | 31+102062828 | e.spitzer@ecri-trials.com |
| Name | Affiliation | Role |
|---|---|---|
| Ernest Spitzer, MD | European Cardiovascular Research Institute | Study Director |
| David E Kandzari, MD | Piedmont Heart Institute | Principal Investigator |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |