Test of Long-Term Safety and Efficacy of Sirolimus-Permanent-Polymer Eluting Stent (Cypher)- and Sirolimus-Polymer-free Eluting Stents (PPS/PFS) Assessed by Optical Coherence Tomography (PPS/PFS-OCT)
Pilop Trial of OCT-determined Coverage of Permanent or Polymer-free Sirolimus Eluting Stent at Long Term
研究概览
地位
条件
详细说明
The mid-term efficacy of drug-eluting stents has been well-established, but there is an ongoing debate on the potential of an increased incidence of late stent thrombosis, particularly after discontinuation of thienopyridine therapy, as well as of delayed onset of restenosis or catch-up phenomenon with permanent polymer-based DES. The extent of strut coverage with reduction of exposed thrombogenic material has been shown to be associated with the inflammatory reaction grade and with the incidence of stent thrombosis. The optical coherence tomography (OCT) is an intravascular imaging modality based on light. The principle is similar to intravascular ultrasound, but due to the much shorter wave length of light, it offers a much better resolution up to 10µm, enabling the exact determination of strut coverage, neointimal thickness, vessel size, presence of dissections, and even the presence of inflammation.
Patients who received a polymer-free or a permanent-polymer sirolimus-eluting stent about 5 years ago without in-segment intervention since, will be evaluated by OCT regarding the healing pattern and the late lumen loss of the stent.
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
Bavaria
-
Munich、Bavaria、德国、81675
- 招聘中
- Klinikum rechts der Isar
-
接触：
- Steffen Massberg, MD
- 电话号码：4025 +49 89 12 18
- 邮箱：massberg@dhm.mhn.de
-
Munich、Bavaria、德国、80636
- 招聘中
- Deutsches Herzzentrum Muenchen
-
接触：
- Julinda Mehilli, MD
- 电话号码：4582 +49 89 12 18
- 邮箱：mehilli@dhm.mhn.de
-
接触：
- Klaus Tiroch, MD
- 电话号码：4578 +49 89 12 18
- 邮箱：tiroch@dhm.mhn.de
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients older than age 18 with with previous implantation of polymer-free or permanent-polymer sirolimus-eluting stents 5 years ago due to ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% stenosis located in native coronary vessels.
- Written, informed consent by the patient or her/his legally-authorized representative for participation in the study and assessment by OCT.
- In women with childbearing potential a negative pregnancy test is mandatory.
Exclusion Criteria:
- Intervention in the segment of the study stent after the index procedure
- Target lesion located in the left main trunk.
- In-stent restenosis with difficulty to pass the OCT device
- Acute myocardial infarction
- Known allergy to the study medications: Sirolimus, rapamycin, probucol or stainless steel.
- Pregnancy (present, suspected or planned) or positive pregnancy test.
- Patient's inability to fully cooperate with the study protocol.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Arm 1
Sirolimus-Permanent-Polymer Eluting Stent
|
due randomization sirolimus-permanent-polymer eluting stent was implanted
其他名称：
|
|
有源比较器：Arm 2
Sirolimus-Polymer-free Eluting Stent
|
due randomization sirolimus-polymer-free eluting stent was implanted
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Degree of stent strut coverage after 5 years assessed by OCT for each visible strut segment
大体时间：5 years
|
5 years
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Percentage of malapposed strut assessed by OCT
大体时间：5 years
|
5 years
|
|
Percentage of uncovered malapposed struts assessed by OCT
大体时间：5 years
|
5 years
|
|
Morphologic differences of neointima between stents
大体时间：5 years
|
5 years
|
|
Late lumen loss at 5 years assessed by OCT
大体时间：5 years
|
5 years
|
合作者和调查者
调查人员
- 首席研究员：Klaus Tiroch, MD、Deutsches Herzzentrum Muenchen
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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