Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03918070 |
| Other study ID # |
2018-A03455-50 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 17, 2019 |
| Est. completion date |
May 24, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Translumina GmbH |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
