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

Ischemic Heart Disease Clinical Trial

— e-Yukon  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05703646
• Other study ID #: e-Yukon Global Registry
• Status: Recruiting
• Start date: March 30, 2023
• Est. completion date: March 30, 2026

Study information

• Verified date: November 2023
• Source: Translumina GmbH
• Contact: NANCY CHUGH
• Phone: +91-9996235253
• Email: drnancychugh[@]translumina.in
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: March 30, 2026
• Est. primary completion date: March 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
United Arab Emirates	Al Qassimi hospital	Sharjah

Sponsors (2)

Lead Sponsor	Collaborator
Translumina GmbH	EVAMED

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Lesion Failure	Defined as the composite of cardiac death, target-vessel myocardial infarction and clinically indicated target lesion revascularization	12 months
Secondary	Device success	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).	12 months
Secondary	Procedure Success	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.	12 months
Secondary	All cause death	Defined as the rate of death from any cause	12 months
Secondary	Cardiac death	Defined as death resulting from cardiovascular causes	12 months
Secondary	Myocardial infarction	Defined as the rate of myocardial infarction	12 months
Secondary	Target-vessel myocardial infarction	Defined as a myocardial infarction occurring on the stented target vessel	12 months
Secondary	Clinically driven target lesion revascularization	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	12 months
Secondary	Any revascularization	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.	12 months
Secondary	Stent Thrombosis	Defined as a thrombotic occlusion of a coronary stent (definite or probable, as per Academic Research Consortium definitions)	12 months