Clinical trial NCT03918070: Observatory to Assess the Yukon Choice PC & the Yukon Chrome PC Sirolimus Eluting Bioabsorbable Polymer Stents Systems
Official title: Multicenter Observatory to Assess the Yukon Choice PC & the Yukon Chrome PC Sirolimus Eluting Bioabsorbable Polymer Stents Systems in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronaropathy
Lead sponsor: Translumina GmbH
Sponsor class: INDUSTRY
Collaborators: name: EVAMED
First posted: 2019-04-17
Enrollment: 2722
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The primary endpoint is Target Lesion Failure (TLF) rate at 12 months follow-up
timeFrame: 12 months follow-up
Secondary outcomes:
measure: Device Success
timeFrame: 12 months follow-up
measure: Procedure Success
timeFrame: 12 months follow-up
measure: Reperfusion
timeFrame: 12 months follow-up
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Clinique Axium
city: Colmar
country: France
facility: Hopital A. Schweitzer - Ghca
city: Compiègne
country: France
facility: Centre Hospitalier de Compiègnes
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
city: Essey-lès-Nancy
country: France
facility: Clinique Louis Pasteur
city: Grenoble
country: France
facility: GHM Grenoble
city: Haguenau
country: France
facility: Centre Hospitalier Haguenau
city: Marseille
country: France
facility: Hopital privé Beauregard
city: Montauban
country: France
facility: Clinique Pont de Chaume
city: Nantes
country: France
facility: Hopital Privé du Confluent
city: Périgueux
country: France
facility: Centre Hospitalier de Périgueux
city: Quimper
country: France
facility: Centre Hospitalier de Quimper
city: Rennes
country: France
facility: Clinique Saint Hilaire
city: Rennes
country: France
facility: Polyclinique Saint-Laurent
city: Saint-Malo
country: France
facility: Centre Hospitalier de Saint Malo
city: Soissons
country: France
facility: Centre Hospitalier de Soissons
city: Tarbes
country: France
facility: Centre Hospitalier de Bigorre
city: Toulouse
country: France
facility: Clinique Pasteur
city: Vannes
country: France
facility: Centre Hospitalier de Vannes
Study officials:
affiliation: Clinique Pasteur
name: Didié Tchétché, Dr
role: PRINCIPAL_INVESTIGATOR
References: