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

Recruiting

• Conditions: Ischemic Heart Disease

• Registration Number: NCT05703646
• Lead Sponsor: Translumina GmbH

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

Study Timeline

• Study First Submitted: 2023-01-19
• Study First Submitted QC: 2023-01-19
• Study First Posted: 2023-01-30
• Study Start: 2023-03-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-27
• Primary Completion: 2026-03-30
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Stent Thrombosis	12 months	Defined as a thrombotic occlusion of a coronary stent (definite or probable, as per Academic Research Consortium definitions)
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
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
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.

Trial Locations

Locations (1)

Al Qassimi hospital; 🇦🇪 Sharjah, United Arab Emirates