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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-30

Study Completion Date

2026-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* 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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ischemic Heart Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

ROBERT BYRNE, Professor

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Research RCSI University of Medicine and Health Sciences, Dublin, Ireland

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Al Qassimi hospital

Sharjah city, , United Arab Emirates

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Arab Emirates

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

NANCY CHUGH

Role: CONTACT

[email protected]

+91-9996235253

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

ALNOORYANI Arif

Role: primary