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NCT05703646
Safety and Clinical Performance of the Yukon Choice PC, Yukon Chrome PC & Yukon Choice Flex Stents in Routine Practice
Conditions: Ischemic Heart Disease
Sex: All
Ages: 18 Years – 80 Years
Enrollment: 5000
Sponsor: Translumina GmbH
Summary
The goal of this observational study is to collect safety and performance information in the setting of a large-scale clinical registry.Patients meeting the selection criteria will be included, in chronological order of their implantation.
This registry does not require any additional procedures, follow-up interventions, or ionizing radiation for patients.The inclusion period is planned to last 2 years, starting in Q1 2023.
The study will be complete when data on all patient's follow-up for one year have been collected.
Eligibility Criteria
Inclusion Criteria:Any patient who was implanted only with a Yukon Choice PC, a Yukon Chrome PC or/and a Yukon Choice Flex stent within previous 2 days.Patient ≥ 18 years old.Male or non-pregnant female patient (Note: females of childbearing potential must have a negative pregnancy test prior to enrollment in the study).Exclusion Criteria:Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.Co-morbid condition(s) that could limit the patient's ability to participate in the trial or to comply with follow-up requirements or impact the scientific integrity of the trial.Concurrent medical condition with a life expectancy of less than 12 months.
Source: ClinicalTrials.gov (NCT05703646). StuddyBuddy aggregates publicly available trial information.