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

NCT03918070 | Active Not Recruiting

• 1 other identifier: 2018-A03455-50
• Study Type: observational
• Target: 2,722
• Locations: 1 country
• Sites: 19

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.

Conditions

Coronaropathy

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months follow-up

Secondary Outcomes (3)

• Device Success

  12 months follow-up

• Procedure Success

  12 months follow-up

• Reperfusion

  12 months follow-up

Interventions

Yukon Choice PC and Yukon Chrome PC DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Translumina GmbH: lead
• EVAMED: collaborator

Study Sites (19)

Clinique Axium

Aix-en-Provence, France

Location

Hopital A. Schweitzer - Ghca

Colmar, France

Location

Centre Hospitalier de Compiègnes

Compiègne, France

Location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France

Location

Clinique Louis Pasteur

Essey-lès-Nancy, France

Location

GHM Grenoble

Grenoble, France

Location

Centre Hospitalier Haguenau

Haguenau, France

Location

Hopital privé Beauregard

Marseille, France

Location

Clinique Pont de Chaume

Montauban, France

Location

Hopital Privé du Confluent

Nantes, France

Location

Centre Hospitalier de Périgueux

Périgueux, France

Location

Centre Hospitalier de Quimper

Quimper, France

Location

Clinique Saint Hilaire

Rennes, France

Location

Polyclinique Saint-Laurent

Rennes, France

Location

Centre Hospitalier de Soissons

Soissons, France

Location

Centre Hospitalier de Saint Malo

St-Malo, France

Location

Centre Hospitalier de Bigorre

Tarbes, France

Location

Clinique Pasteur

Toulouse, France

Location

Centre Hospitalier de Vannes

Vannes, France

Location

Study Officials

• Didié Tchétché, Dr

  Clinique Pasteur

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 17, 2019
• Study Start: April 17, 2019
• Primary Completion: April 24, 2024
• Study Completion: May 24, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (19)