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

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ClinicalTrials.gov Identifier: NCT03918070
Recruitment Status : Not yet recruiting
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
EVAMED
Information provided by (Responsible Party):
Translumina GmbH

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 2000 patients from 14 to 30 sites in France.


Condition or disease Intervention/treatment
Coronaropathy 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.


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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Observatory to Assess the Yukon Choice PC & the Yukon Chrome PC Sirolimus Eluting Bioabsorbable Polymer Stents Systems in Routine Clinical Practice
Estimated Study Start Date : April 17, 2019
Estimated Primary Completion Date : April 17, 2019
Estimated Study Completion Date : April 17, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus


Intervention Details:
  • Device: Yukon Choice PC and Yukon Chrome PC
    The Yukon Choice PC & the Yukon Chrome PC Sirolimus Eluting Bioabsorbable Polymer Coronary Stent Systems are indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease.


Primary Outcome Measures :
  1. The primary endpoint is Target Lesion Failure (TLF) rate at 12 months follow-up [ Time Frame: 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.


Secondary Outcome Measures :
  1. Device Success [ Time Frame: 12 months follow-up ]
    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)

  2. Procedure Success [ Time Frame: 12 months follow-up ]
    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.

  3. Reperfusion [ Time Frame: 12 months follow-up ]
    Reperfusion measured by TIMI flow at the end of the procedure.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918070


Contacts
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Contact: Pierre Jullien +33 2 31 93 21 18 pierre.jullien@evamed.fr
Contact: Béatrice Godefroy +33 623 822 906 Beatrice.Godefroy@translumina.de

Locations
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France
Clinique Pasteur Not yet recruiting
Toulouse, France
Contact: Didié TCHETCHE, Dr         
Sponsors and Collaborators
Translumina GmbH
EVAMED
Investigators
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Principal Investigator: Didié Tchétché, Dr Clinique Pasteur

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Responsible Party: Translumina GmbH
ClinicalTrials.gov Identifier: NCT03918070     History of Changes
Other Study ID Numbers: 2018-A03455-50
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs