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

Phase

N/A

Condition

Heart Attack (Myocardial Infarction)

Angina

Thrombosis

Treatment

N/A

Clinical Study ID

NCT05703646

e-Yukon Global Registry

Ages 18-80
All Genders

Study 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

Inclusion Criteria:

Any patient who was implanted only with a Yukon Choice PC, a Yukon Chrome PC or/and aYukon Choice Flex stent within previous 2 days.
Patient ≥ 18 years old.
Male or non-pregnant female patient (Note: females of childbearing potential must havea negative pregnancy test prior to enrollment in the study).

Exclusion

Exclusion Criteria:

Currently enrolled in another investigational device or drug trial that has notcompleted the primary endpoint or that clinically interferes with the current studyendpoints.
Co-morbid condition(s) that could limit the patient's ability to participate in thetrial or to comply with follow-up requirements or impact the scientific integrity ofthe trial.
Concurrent medical condition with a life expectancy of less than 12 months.

Study Design

March 30, 2023

March 30, 2026

Study 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

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

Connect with a study center

Al Qassimi hospital
Sharjah,
United Arab Emirates
Active - Recruiting

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