e-Yukon Global Registry
Research type
Research Study
Full 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.
IRAS ID
325444
Contact name
Mohaned Egred
Contact email
Sponsor organisation
Translumina
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 30 days
Research summary
The purpose of this registry is to use the information collected to evaluate the safety and performance of the following stents:
• Yukon Choice PC
• Yukon Chrome PC
and/or
• Yukon Choice Flex Sirolimus Eluting Bioabsorbable Polymer Coronary Stent Systems
They are all commercially available in Europe, have been used in many angioplasty procedures throughout the world and all carry the CE mark. We hope information collected from the registry will help other patients in the future by improving the knowledge of the doctors. At least 5,000 participants with coronary artery disease who are planned for angioplasty with Yukon Choice PC, Yukon Chrome PC and/or Yukon Choice Flex Sirolimus Eluting Bioabsorbable Polymer Coronary Stent Systems, from approximately 60-80 centers globally will take part in this registry. An angioplasty involves a catheter with a balloon being passed into the artery. This is then inflated to relieve the narrowing or blockage. Angioplasty is often combined with the placement of a small wire mesh tube called a stent, into the artery. The stent helps prop the artery open, decreasing its chance of narrowing again. Most stents are coated with medication to help keep the artery open (drug-eluting stents). As you have been treated by angioplasty with Yukon Choice PC, Yukon Chrome PC and/or Yukon Choice Flex Sirolimus Eluting Bioabsorbable Polymer Coronary Stent Systems and per the discretion of your treating doctor, you will be asked if you want to participate in the study. If you agree to participate in this research study, you will be asked to review and sign the informed consent form which is at the end of this document to state your agreement to take part in this study.
During the study, you will meet with the study doctor and his/her staff for an inclusion visit and for follow-up visits at discharge from hospital /clinic and for at least 2 appointments over a period of 1 year in clinic or by phone call.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
23/YH/0139
Date of REC Opinion
2 Aug 2023
REC opinion
Further Information Favourable Opinion