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

Sponsor

Translumina GmbH (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05703646

Collaborator

EVAMED (Other)

5,000

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Heart Disease

Detailed 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

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

5000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Safety and Clinical Performance of the Yukon Choice PC, Yukon Chrome PC & Yukon Choice Flex Sirolimus Eluting Bioabsorbable Polymer Stents Systems in Routine Clinical Practice: e-Yukon Global Registry.

Anticipated Study Start Date :

Feb 15, 2023

Anticipated Primary Completion Date :

Feb 15, 2026

Anticipated Study Completion Date :

Feb 15, 2026

Outcome Measures

Primary Outcome Measures

Target Lesion Failure [12 months]
Defined as the composite of cardiac death, target-vessel myocardial infarction and clinically indicated target lesion revascularization

Secondary Outcome Measures

Device success [12 months]
Defined as successful delivery and deployment of the assigned device at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-stent residual stenosis of <30% (by visual estimation).
Procedure Success [12 months]
Device success without the occurrence of an ischemia-driven major adverse cardiac event during the hospital stay to a maximum of first seven days post index procedure.
All cause death [12 months]
Defined as the rate of death from any cause
Cardiac death [12 months]
Defined as death resulting from cardiovascular causes
Myocardial infarction [12 months]
Defined as the rate of myocardial infarction
Target-vessel myocardial infarction [12 months]
Defined as a myocardial infarction occurring on the stented target vessel
Clinically driven target lesion revascularization [12 months]
Defined as a repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication involving the target lesion
Any revascularization [12 months]
defined as clinically driven target lesion revascularization or angiographically driven target lesion revascularization, performed due to angiographic detection of significant restenosis in a patient who is clinically asymptomatic.
Stent Thrombosis [12 months]
Defined as a thrombotic occlusion of a coronary stent (definite or probable, as per Academic Research Consortium definitions)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.