Safety and Clinical Performance of the Yukon Choice PC, Yukon Chrome PC & Yukon Choice Flex Stents in Routine Practice (e-Yukon)

Translumina

Status: Enrolling

Conditions: Ischemic Heart Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05703646

e-Yukon Global Registry

Details and patient eligibility

About

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.

Full 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

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.