CoronaropathyYuChooSeRNCT03918070
Observatory to Assess the Yukon Choice PC & the Yukon Chrome PC Sirolimus Eluting Bioabsorbable Polymer Stents Systems
An observational study of Coronaropathy, run by Translumina GmbH at 19 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronaropathy
- What is being tested?
- Yukon Choice PC and Yukon Chrome PC
- Type of treatment
- Medical device
- How many people
- 2,722 participants
- Where
- 19 sitesFrance
- Study dates
- 17 Apr 2019to 24 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
France19 sites
Clinique Axium
Aix-en-Provence
Hopital A. Schweitzer - Ghca
Colmar
Centre Hospitalier de Compiègnes
Compiègne
Centre Hospitalier Sud Francilien
Corbeil-Essonnes
Clinique Louis Pasteur
Essey-lès-Nancy
GHM Grenoble
Grenoble
Centre Hospitalier Haguenau
Haguenau
Hopital privé Beauregard
Marseille
Clinique Pont de Chaume
Montauban
Hopital Privé du Confluent
Nantes
Centre Hospitalier de Périgueux
Périgueux
Centre Hospitalier de Quimper
Quimper
Clinique Saint Hilaire
Rennes
Polyclinique Saint-Laurent
Rennes
Centre Hospitalier de Soissons
Soissons
Centre Hospitalier de Saint Malo
St-Malo
Centre Hospitalier de Bigorre
Tarbes
Clinique Pasteur
Toulouse
Centre Hospitalier de Vannes
Vannes
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronaropathy
- Being tested
- Yukon Choice PC and Yukon Chrome PC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yukon Choice PC and Yukon Chrome PCDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months follow-up
Secondary outcomes (3)
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)
Measured: 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.
Measured: 12 months follow-up
Reperfusion
Reperfusion measured by TIMI flow at the end of the procedure.
Measured: 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start17 Apr 2019
- Primary completion24 Apr 2024
- Study completion24 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronaropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,722 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translumina GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Responsible party
- Sponsor
- Investigators
- Didié Tchétché, Dr, Principal investigator, Clinique Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918070
- Sponsor's protocol ID
- 2018-A03455-50
- Acronym
- YuChooSeR
- Status last verified
- Sep 2026
- First submitted
- 12 Apr 2019
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Observatory to Assess the Yukon Choice PC & the Yukon Chrome PC Sirolimus Eluting Bioabsorbable Polymer Stents Systems in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT03918070
- Acronym / sponsor ID
- YuChooSeR / 2018-A03455-50
- Conditions
- Coronaropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,722 participants (actual)
- Lead sponsor
- Translumina GmbHIndustry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 24 May 2024 (actual)
- First posted
- 17 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yukon Choice PC and Yukon Chrome PCThe 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. | Device | – |
Primary outcome
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.
3 secondary outcomes
Device Success
Time frame: 12 months follow-up
Procedure Success
Time frame: 12 months follow-up
Reperfusion
Time frame: 12 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didié Tchétché, Dr principal investigator
Clinique Pasteur
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronaropathy, run by Translumina GmbH at 19 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is Target Lesion Failure (TLF) rate at 12 months follow-up (time frame: 12 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.