NCT05703646

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

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.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Translumina GmbH · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Ischemic Heart Disease

Timeline

• Start date: 2023-03-30
• Primary completion: 2026-03-30
• Completion: 2026-03-30
• First posted: 2023-01-30
• Last updated: 2023-11-27

Locations

1 site across 1 country: United Arab Emirates