Yukon Choice PC 및 Yukon Chrome PC Sirolimus Eluting 생체흡수성 폴리머 스텐트 시스템을 평가하기 위한 관측소 (YuChooSeR)
일상적인 임상 실습에서 Yukon Choice PC 및 Yukon Chrome PC Sirolimus Eluting 생체흡수성 폴리머 스텐트 시스템을 평가하기 위한 다기관 관측소
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Aix-en-Provence, 프랑스
- Clinique Axium
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Colmar, 프랑스
- Hopital A. Schweitzer - Ghca
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Compiègne, 프랑스
- Centre Hospitalier de Compiègnes
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Corbeil-Essonnes, 프랑스
- Centre Hospitalier Sud Francilien
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Essey-lès-Nancy, 프랑스
- Clinique Louis Pasteur
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Grenoble, 프랑스
- GHM Grenoble
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Haguenau, 프랑스
- Centre Hospitalier Haguenau
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Marseille, 프랑스
- Hopital privé Beauregard
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Montauban, 프랑스
- Clinique Pont de Chaume
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Nantes, 프랑스
- Hopital Privé du Confluent
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Périgueux, 프랑스
- Centre Hospitalier de Périgueux
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Quimper, 프랑스
- Centre Hospitalier de Quimper
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Rennes, 프랑스
- Polyclinique Saint-Laurent
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Rennes, 프랑스
- Clinique Saint Hilaire
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Soissons, 프랑스
- Centre Hospitalier de Soissons
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St-Malo, 프랑스
- Centre Hospitalier de Saint Malo
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Tarbes, 프랑스
- Centre Hospitalier de Bigorre
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Toulouse, 프랑스
- Clinique Pasteur
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Vannes, 프랑스
- Centre Hospitalier de Vannes
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The primary endpoint is Target Lesion Failure (TLF) rate at 12 months follow-up
기간: 12 months follow-up
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Device Success
기간: 12 months follow-up
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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) |
12 months follow-up
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Procedure Success
기간: 12 months follow-up
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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. |
12 months follow-up
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Reperfusion
기간: 12 months follow-up
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Reperfusion measured by TIMI flow at the end of the procedure. |
12 months follow-up
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2018-A03455-50
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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