[未经美国FDA批准或清除的设备试验]
The primary objective of the study is to evaluate the long-term safety and effectiveness of the Advance Evero™ 18 Everolimus-coated Percutaneous Transluminal Angioplasty Balloon Catheter (hereafter referred to as the Evero drug-coated balloon [DCB]) in the treatment of the femoropopliteal artery lesions in patients with peripheral arterial disease (PAD). Specifically, the Randomized-Controlled Trial (RCT) is designed to demonstrate non-inferior safety and non-inferior effectiveness of the Evero DCB when compared to commercially available paclitaxel DCBs (pDCBs).
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Noah Shields
- 电话号码：321174 765-463-7537
- 邮箱：noah.shields@cookmedical.com
学习地点
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California
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Long Beach、California、美国、90822
- 招聘中
- Long Beach Veterans Administration Hospital/SCIRE Research
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Connecticut
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New Haven、Connecticut、美国、06510
- 招聘中
- Yale New Haven Hospital
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District of Columbia
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Washington D.C.、District of Columbia、美国、20007
- 招聘中
- Medstar Georgetown University Hopsital
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Florida
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Gainesville、Florida、美国、32605
- 招聘中
- The Cardiac and Vascular Institute
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Jacksonville、Florida、美国、32256
- 招聘中
- First Coast Cardiovascular Institute
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Miami、Florida、美国、33176
- 招聘中
- Baptist Cardiac and Vascular Institute
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Iowa
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Davenport、Iowa、美国、52801
- 招聘中
- Midwest Cardiovascular Research Foundation
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Michigan
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Bay City、Michigan、美国、48708
- 招聘中
- McLaren Bay Region Hospital
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Mississippi
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Tupelo、Mississippi、美国、33801
- 招聘中
- North Mississippi Medical Center
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New Hampshire
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Lebanon、New Hampshire、美国、03756
- 招聘中
- Dartmouth-Hitchcock Medical Center
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New Jersey
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Camden、New Jersey、美国、08103
- 招聘中
- Cooper University Hospital
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South Carolina
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Greenville、South Carolina、美国、26905
- 招聘中
- Prisma Health Memorial
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Texas
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Dallas、Texas、美国、75235
- 招聘中
- University of Texas Southwestern
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Houston、Texas、美国、77030
- 招聘中
- Houston Methodist Hospital
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Humble、Texas、美国、77338
- 招聘中
- Vital Heart and Vein
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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:
- Documented PAD with Rutherford classification 2 - 4; and
- De novo or restenotic (non-stented) target lesion located in the native superficial femoral artery (SFA), popliteal artery (P1 or P2), or both native SFA and popliteal arteries.
Exclusion Criteria:
General Exclusion Criteria
- Less than 18 years old;
- Inability or refusal to give informed consent by the patient or legally authorized representative;
- Life expectancy ≤ 12 months, per investigator assessment;
- Pregnant (or if absence of pregnancy is not verified by negative pregnancy test within 7 days of planned procedure), lactating, planning to become pregnant within 12 months of the planned procedure, or unwilling to use contraception for 12 months following the planned procedure;
- Unable or unwilling to comply with the follow-up schedule; or
- Simultaneously participating in another investigational drug or device study unless the patient is at least 30 days beyond the primary endpoint of any previous study.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Evero DCB
Treatment with Evero drug-coated balloon to apply local treatment with everolimus |
PTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries |
|
有源比较器：Paclitaxel-coated DCB
Treatment with commercially-available drug-coated balloons to apply local treatment with paclitaxel |
PTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Primary safety endpoint
大体时间：30 days (death); 12 months (amputation and CD-TLR)
|
The primary safety endpoint is a composite assessment of freedom from device- or procedure-related death, freedom from target limb major amputation, and freedom from clinically-driven target lesion revascularization (CD-TLR) |
30 days (death); 12 months (amputation and CD-TLR)
|
|
Primary effectiveness endpoint
大体时间：12 months
|
The primary effectiveness endpoint is primary patency defined as peak systolic velocity ratio ≤2.4 assessed by duplex ultrasound at 12 months and freedom from CD-TLR. |
12 months
|
合作者和调查者
调查人员
- 学习椅：Eric Secemsky, MD、Beth Israel Deaconess Medical Center
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 24-04
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after publication of the results from this study and ending 5 years after initial publication. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.
html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
IPD 共享时间框架
Data underlying the results reported in this clinical study will be made available for request after publication of the results from this study and ending 5 years after initial publication.
IPD 共享访问标准
Qualified scientific researchers
IPD 共享支持信息类型
- 研究方案
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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