Clinical trial NCT05703646: Safety and Clinical Performance of the Yukon Choice PC, Yukon Chrome PC & Yukon Choice Flex Stents in Routine Practice
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Heart Disease
Keywords: stent
ischemic heart disease
registry
international
routine practice
Lead sponsor: Translumina GmbH
Sponsor class: INDUSTRY
Collaborators: name: EVAMED
First posted: 2023-01-30
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with coronary artery lesions in native coronary arteries ranging from 2.00 mm to 4.00 mm

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.

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

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 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.

Primary outcomes:
measure: Target Lesion Failure
timeFrame: 12 months
Secondary outcomes:
measure: Device success
timeFrame: 12 months
measure: Procedure Success
timeFrame: 12 months
measure: All cause death
timeFrame: 12 months
measure: Cardiac death
timeFrame: 12 months
measure: Myocardial infarction
timeFrame: 12 months
measure: Target-vessel myocardial infarction
timeFrame: 12 months
measure: Clinically driven target lesion revascularization
timeFrame: 12 months
measure: Any revascularization
timeFrame: 12 months
measure: Stent Thrombosis
timeFrame: 12 months
Other outcomes:
Locations:
city: Sharjah
country: United Arab Emirates
facility: Al Qassimi hospital
Study officials:
affiliation: Cardiovascular Research RCSI University of Medicine and Health Sciences, Dublin, Ireland
name: ROBERT BYRNE, Professor
role: PRINCIPAL_INVESTIGATOR
References: