Observatory to Assess the Yukon Choice PC & the Yukon Chrome PC Sirolimus Eluting Bioabsorbable Polymer Stents Systems (YuChooSeR)

Multicenter Observatory to Assess the Yukon Choice PC & the Yukon Chrome PC Sirolimus Eluting Bioabsorbable Polymer Stents Systems in Routine Clinical Practice

The TRANSLUMINA GmbH YuChooSeR Observatory is a prospective, multicentric post-marketing observatory designed to evaluate large scale safety and reliability of the Yukon Choice PC and the Yukon Chrome PC stents systems use in routine, clinical practice.

This based observatory will enroll 3000 patients to 30 sites in France.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronaropathy
• Intervention / Treatment: Device: Yukon Choice PC and Yukon Chrome PC

Detailed Description

TRANSLUMINA GmbH has launched clinical programs to demonstrate the safety and efficacy of its technology.

The Translumina Yukon Choice PC drug-eluting stent, coated with Rapamycin (Sirolimus) and the biodegradable component polylactide (PLA), has an excellent history of pre-clinical and clinical results.

The Yukon Chrome PC has the identical coating technique and coating properties (dosage, thickness) like the clinically proven Yukon Choice PC.

In two independent trials ISAR-TEST 3 and ISAR-TEST 4 the Yukon DES platform showed angiographic and clinical equivalence with the Cypher stent after 1 year and 3 years of follow-up.

Latest clinical data, published by G.Stefanini et al, show the excellent long-term outcome of the Yukon biodegradable polymer DES technology in a meta-analysis, comparing the clinical outcome after 4 years in more than 4000 patients with the Cypher stent. This analysis shows for the first time that the definite Very Late Stent Thrombosis (VLST) can be reduced statistically significant by using the biodegradable PLA polymer coating technology of the Yukon DES.

An additional sub-group analysis shows also benefit in difficult patient groups like diabetics and patients with acute myocardial infarkt.

Due to this excellent clinical outcome the Yukon DES technology is recommended by the latest ESC guidelines for myocardial revascularization.

The final 5 years long-term clinical follow-up of the ISAR-TEST 4 randomized controlled clinical trial showed excellent safety and efficacy data for the Yukon DES when compared with the Cypher and Xience V stent. The definite and probable stent thrombosis was only 1,2% for the Yukon compared to 1,4% and 2,4% for the 2 permanent polymer coated competitor DES.

In a continued approach to collect safety and efficiency data on its products, TRANSLUMINA GmbH is determined to collect safety and efficiency information at a very large scale. Based on all this, the Yukon Choice PC & the Yukon Chrome PC stents have been designed to treat coronary arteries in a relatively easy and simple-to-achieve manner, while providing a higher level of clinical efficacy.

Additionally, the Observatory is aimed to provide a learning tool that will help to define best practices/techniques as all results will be fed back to participants and to a larger audience through publications.

In this Observatory, analyses will be performed per clinical presentation and per stent type.

• Study Type: Observational
• Enrollment (Actual): 2722

Contacts and Locations

Study Locations

• France
  • Aix-en-Provence, France
    • Clinique Axium
  • Colmar, France
    • Hôpital A. Schweitzer - GHCA
  • Compiègne, France
    • Centre Hospitalier de Compiègnes
  • Corbeil-Essonnes, France
    • Centre Hospitalier Sud Francilien
  • Essey-lès-Nancy, France
    • Clinique Louis Pasteur
  • Grenoble, France
    • GHM Grenoble
  • Haguenau, France
    • Centre Hospitalier Haguenau
  • Marseille, France
    • Hôpital privé Beauregard
  • Montauban, France
    • Clinique Pont de Chaume
  • Nantes, France
    • Hopital prive du Confluent
  • Périgueux, France
    • Centre Hospitalier de Périgueux
  • Quimper, France
    • Centre Hospitalier de Quimper
  • Rennes, France
    • Polyclinique Saint-Laurent
  • Rennes, France
    • Clinique Saint Hilaire
  • Saint-Malo, France
    • Centre Hospitalier De Saint Malo
  • Soissons, France
    • Centre Hospitalier de Soissons
  • Tarbes, France
    • Centre Hospitalier de Bigorre
  • Toulouse, France
    • Clinique Pasteur
  • Vannes, France
    • Centre Hospitalier de Vannes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic ischemic heart disease requiring stenting. All patients selected by the investigator to receive a Yukon Choice PC and/or a Yukon Chrome PC stent can be enrolled. Patient must be over 18 years old and be informed verbally and in writing about the nature and aim of the study.

Description

Inclusion Criteria:

• Any patient suitable for implantation with a Yukon Choice PC or a Yukon Chrome PC stent according to current guidelines can be enrolled in this observatory
• Patient must be over 18 years old.

Exclusion Criteria:

• Patient not able to understand the information given for collection, transfer and processing of personal data before participation, may not be enrolled in this observatory.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary endpoint is Target Lesion Failure (TLF) rate at 12 months follow-up	Target Lesion Failure (TLF) is defined as the composite of cardiac death, target-vessel myocardial Infarction and clinically indicated target lesion revascularization (TLR) by percutaneous or surgical methods.	12 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Success	Device Success defined as successful delivery and deployment of the assigned device at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-stent residual stenosis of <30% (by visual estimation)	12 months follow-up
Procedure Success	Procedure Success defined as Device Success without the occurrence of ischemia-driven major adverse cardiac event (ID-MACE) during the hospital stay to a maximum of first seven days post index procedure.	12 months follow-up
Reperfusion	Reperfusion measured by TIMI flow at the end of the procedure.	12 months follow-up

Collaborators and Investigators

• Sponsor: Translumina GmbH
• Collaborators: EVAMED
• Investigators: Principal Investigator: Didié Tchétché, Dr, Clinique Pasteur

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2019
• Primary Completion (Actual): April 24, 2024
• Study Completion (Estimated): May 24, 2024

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (Actual): April 17, 2019

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2018-A03455-50

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No