Ignite Creation Date:
2024-05-06 @ 1:01 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03918070
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2019-04-12
Brief Title:
Observatory to Assess the Yukon Choice PC the Yukon Chrome PC Sirolimus Eluting Bioabsorbable Polymer Stents Systems
Sponsor:
Translumina GmbH
Organization:
Translumina GmbH
Study Overview
Official Title:
Multicenter Observatory to Assess the Yukon Choice PC the Yukon Chrome PC Sirolimus Eluting Bioabsorbable Polymer Stents Systems in Routine Clinical Practice
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
YuChooSeR
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
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 GStefanini 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 12 for the Yukon compared to 14 and 24 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 practicestechniques 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
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 GStefanini 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 12 for the Yukon compared to 14 and 24 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 practicestechniques 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None