Overview
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.
Description
- Prospective, observational, noninterventional, multicenter, international clinical
registry
- Allocation: consecutively treated patients, non-randomized
- Masking: None (open label)
- Observational model: Longitudinal
- Inclusion period: 2 years
- Follow-up period: at 1 year
- Study duration: 3 years
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.
List of visits:
V0: During hospitalization: consultation baseline, data of the intervention and data at discharge
V1: consultation at 30 days Follow-Up
V2: consultation at 12 months Follow-Up
Eligibility
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.