IVUS CHIP UPP Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorECRI bv
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient must be ≥18 years of age and self-identify within a US census-defined minority
Angiographic heavy calcification
Ostial lesions
True bifurcation lesions involving side-branches >2.5mm
Disqualifiers
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
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
IVUS
DeviceIntravascular Ultrasound
Treatment groups
1,010 Participants
are divided into 1 treatment groupGroup A: IVUS-guided PCI in patients traditionally underrepresented in clinical trials1 intervention
Trial outcomes
Primary outcomes
1
Target-vessel failure (TVF)
TVF is defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-vessel revascularization
Time frame
1 year after enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov