Evaluating the safety and performance of Yukon stents in heart disease patients
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.
This study is testing how safe and effective new Yukon stents are for people with heart disease who have just received them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Translumina GmbH Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Sharjah) |
| Trial ID | NCT05703646 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather safety and performance data on Yukon Choice PC, Yukon Chrome PC, and Yukon Choice Flex stents used in patients with ischemic heart disease. It will involve a large-scale clinical registry that includes patients who have received these stents within the last two days. The study will follow patients for one year after their stent implantation, with consultations at baseline, 30 days, and 12 months. No additional procedures or interventions are required for participants.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have recently received a Yukon stent.
Not a fit: Patients with co-morbid conditions that limit their ability to participate or those with a life expectancy of less than 12 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of Yukon stents, potentially improving treatment options for patients with ischemic heart disease.
How similar studies have performed: Other studies have shown success in evaluating stent performance in similar patient populations, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Sharjah
- Al Qassimi hospital — Sharjah, United Arab Emirates (Recruiting)
Study contacts
- Principal investigator: ROBERT BYRNE, Professor — Cardiovascular Research RCSI University of Medicine and Health Sciences, Dublin, Ireland
- Study coordinator: Nancy Chugh
- Email: drnancychugh@translumina.in
- Phone: +91-9996235253
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.