NCT02953496撤回1 期
A Phase 1 Multi-Center, Dose-Escalation Study of Vonapanitase Administered Percutaneously to the Superficial Femoral or Popliteal Artery in Patients With Peripheral Artery Disease
Proteon Therapeutics1 个研究点 分布在 1 个国家开始时间: 2016年11月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
The research study is designed to assess the technical feasibility and safety of percutaneous administration of vonapanitase to the superficial femoral or popliteal artery in patients with PAD.
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 100 Years（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.
- •ABI <0.90 at rest or with exercise, or a toe-brachial index (TBI) <0.70 if ABI value is >1.30 (non-compressible), or radiographic evidence of PAD that correlates with clinical symptoms.
- •Rutherford category 2-
- •Screening duplex Doppler ultrasound with a SFA or PA lesion with a PSVR >2.
- •De novo lesion, not previously treated by angioplasty, atherectomy, or stent.
- •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.
- •Exclusion Criteria
- •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).
- •Total occlusion of the SFA or PA in the index leg.
- •Planned surgical or endovascular procedures to the affected leg on the day of or within 28 days of study drug administration.
- •Deep vein thrombosis within the past 3 months.
- •Known bleeding disorder.
- •Presence of any arterial aneurysm in the index leg.
- •Known hypercoagulable state (e.g., protein C deficiency, factor V Leiden mutation, prothrombin G20210A mutation).
- •Platelet count <130K, hematocrit <30%, bilirubin or ALT >3.0 times the upper limit of normal.
- •Arterial systolic BP >200 mmHg or diastolic BP >100 mmHg at screening or day of procedure.
- •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.
- •Malignancy or treatment for malignancy within the previous 12 months with the exception localized basal cell or squamous cell skin cancer, or any cancer in situ.
- •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, iodine, lidocaine, prilocaine, or EMLA Cream (lidocaine 2.5% and prilocaine 2.5%).
排除标准
- 未提供
研究组 & 干预措施
vonapanitase
Experimental
干预措施: vonapanitase (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: Up to 6 months following study drug administration
Safety assessments include physical exams, duplex Doppler ultrasound and routine serum chemistry and hematology tests
Technical success of percutaneous injection
时间窗: Intraprocedural
Technical success of study drug administration will be assessed by the extent of circumferential and longitudinal coverage of the artery using a protocol-defined assessment scale
次要结局
未报告次要终点
研究者
研究点 (1)
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