Safety and Clinical Performance of the Yukon Choice PC, Yukon Chrome PC & Yukon Choice Flex Stents in Routine Practice
e-Yukon
1 other identifier
observational
5,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2023
CompletedFirst Posted
Study publicly available on registry
January 30, 2023
CompletedStudy Start
First participant enrolled
March 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2026
CompletedNovember 27, 2023
November 1, 2023
3 years
January 19, 2023
November 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Target Lesion Failure
Defined as the composite of cardiac death, target-vessel myocardial infarction and clinically indicated target lesion revascularization
12 months
Secondary Outcomes (9)
Device success
12 months
Procedure Success
12 months
All cause death
12 months
Cardiac death
12 months
Myocardial infarction
12 months
- +4 more secondary outcomes
Eligibility Criteria
patients with coronary artery lesions in native coronary arteries ranging from 2.00 mm to 4.00 mm
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Translumina GmbHlead
- EVAMEDcollaborator
Study Sites (1)
Al Qassimi hospital
Sharjah city, United Arab Emirates
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ROBERT BYRNE, Professor
Cardiovascular Research RCSI University of Medicine and Health Sciences, Dublin, Ireland
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2023
First Posted
January 30, 2023
Study Start
March 30, 2023
Primary Completion
March 30, 2026
Study Completion
March 30, 2026
Last Updated
November 27, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share