Multicenter Observatory to Assess the Yukon Choice PC & the Yukon Chrome PC Sirolimus Eluting Bioabsorbable Polymer Stents Systems in Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,722
- 试验地点
- 19
- 主要终点
- The primary endpoint is Target Lesion Failure (TLF) rate at 12 months follow-up
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The primary endpoint is Target Lesion Failure (TLF) rate at 12 months follow-up
时间窗: 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.
次要结局
- Reperfusion(12 months follow-up)
- Device Success(12 months follow-up)
- Procedure Success(12 months follow-up)