NCT01616290已完成1 期
Open-Label, Dose-Escalation, Pilot Study of PRT-201 Administered Following Angioplasty in Patients With Peripheral Artery Disease in the Lower Extremity
Proteon Therapeutics2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2012年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Clinical Safety
研究概览
简要总结
The purpose of this study is to determine if it is safe and feasible to apply PRT-201 to the adventitia of arteries following successful angioplasty (PTA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age of at least 18 years
- •Clinical diagnosis of PAD, secondary to atherosclerosis affecting a lower limb
- •Rutherford classification 2-4 (moderate claudication to ischemic rest pain)
- •ABI <0.90 at rest or with exercise, or a toe-brachial index <0.70, or radiographic evidence of PAD that correlates with clinical symptoms
- •De novo lesion, not previously treated by angioplasty or atherectomy
- •Greater than 70% stenosis of the SFA or PA, target lesion length of 10 cm or less, and at least one patent runoff vessel. Short segment occlusions (<10 cm) are acceptable
- •If female and of childbearing potential (premenopausal and not surgically sterile) must have a negative pregnancy test at the screening visit and be willing to use contraception from the time of the screening visit to 1 week following study drug administration. Acceptable methods of birth control include abstinence, barrier methods with spermicide, implants, injectables, oral contraceptives, intra-uterine device, or a vasectomized partner
- •Ability to understand and comply with the requirements of the entire study and communicate with the study team
- •Ability to provide written informed consent using a document that has been approved by the required institutional review board
排除标准
- •Previous treatment with PRT-201
- •Patients in whom arterial insufficiency in the lower extremity is the result of an immunologic or inflammatory non-atherosclerotic disorder (e.g. Buerger's disease, vasculitis)
- •Current severe critical limb ischemia defined as ulceration or gangrene
- •Planned atherectomy of the arteries of the index leg
- •Prior or planned stenting of the target lesion
- •Prior bypass surgery to the target SFA or PA
- •Severe concentric medial calcification of the target lesion thought to interfere with drug delivery to the adventitia that is defined subjectively by the Investigator based on fluoroscopic appearance.
- •History of metastatic cancer
- •Presence of aortic or peripheral artery aneurysm
- •Platelet count <130K, hematocrit <30%, bilirubin or ALT >3.0 times the upper limit of normal
- •Pregnancy, lactation or plans to become pregnant during the course of the study
- •Presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study
- •Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within 90 days prior to signing informed consent
- •Known allergy to contrast media
结局指标
主要结局
Clinical Safety
时间窗: 12 months following PTA and study drug administration
Safety evaluations will be based on adverse events, physical examinations, ultrasounds, vital signs, and clinical laboratory results. Events of interest (EOI) include: acute occlusion, vessel dissection, vessel rupture, aneurysm, pseudoaneurysm, target lesion revascularization, limb amputation, and death.
次要结局
- Technical success of adventitial administration of PRT-201(Immediately following study drug administration)
研究者
研究点 (2)
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