Natural Vascular Scaffolding (NVS) Therapy for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 8
- 主要终点
- Freedom from all-cause mortality, freedom from target limb major amputation, freedom from target lesion revascularization (TLR).
研究概览
简要总结
The NVS Therapy is being studied to evaluate the safety and efficacy to facilitate retention of acute luminal gain, leading to acute hemodynamic improvement in superficial femoral and popliteal arteries with reference vessel diameters between 4.0 and 7.0 mm and lesion lengths less than or equal to 56mm.
详细描述
This is a prospective, non-randomized, multi-center, open label Phase 1 study to assess the safety, pharmacokinetics (PK), and preliminary efficacy trends to applying NVS therapy to de novo lesions in the superficial femoral artery (SFA) and the proximal popliteal artery (PPA) during percutaneous transluminal angioplasty (PTA) in patients with life-style limiting claudication due to obstructive SFA and proximal popliteal artery atherosclerosis. Each investigator will receive supervised training for each procedure.
Eligibility to participate in the study is determined during the screening period and prior to the index procedure with the NVS therapy. Study Data will be analyzed through the Day 365 follow-up visit.
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
- •General Description of Subject Population: Adults with symptoms of claudication and/or rest pain (Rutherford Classification 2, 3, or 4) (see Appendix 3) and angiographic evidence of an atherosclerotic lesion of the superficial femoral artery and/or proximal popliteal artery ≥70% diameter stenosis and < 100% stenosis.
- •Subjects must meet all of the following general eligibility criteria:
- •Subject is at least 18 years of age.
- •Subject (or legally authorized representative [LAR]) understands the study requirements and the treatment procedure and provides written informed consent before any study-specific tests or procedures are performed.
- •Subject is eligible for PTA.
- •Subject is willing to comply with all protocol required follow-up evaluations.
- •Subject has documented Rutherford Classification 2 to 4 (see Appendix 3).
- •Subject has laboratory test results that are within clinically acceptable limits.
- •In investigator's opinion, subject is hemodynamically stable at the time of the index procedure.
- •Subject has a life expectancy of ≥ 1 year in the opinion of the Investigator.
- •Subject is able to tolerate the insertion of a 7F sheath into the common femoral artery (CFA), as determined by the investigator.
- •Subject is able to undergo contralateral access, as determined by the Investigator.
排除标准
- •Subjects must not meet any of the following general eligibility criteria:
- •Subject had cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 3 months prior to enrollment with any residual deficit involving the index lower extremity.
- •Subject has any permanent neurologic defect that may impair ambulation and/or cause non-compliance with the protocol.
- •Subject had a STEMI or NSTEMI within the last 3 months prior to enrollment.
- •Subject is pregnant, breastfeeding, or planning to become pregnant in the next 365 days. Subjects (male and female) must agree to use effective birth control measures for duration of study.
- •Subject is currently receiving oral or intravenous immunosuppressive therapy (e.g., inhaled steroids are not excluded).
结局指标
主要结局
Freedom from all-cause mortality, freedom from target limb major amputation, freedom from target lesion revascularization (TLR).
时间窗: Day 30
The overall composite occurrence of participants free from all-cause mortality, target limb major amputation, target lesion revascularization (TLR) through post-index procedure Day 30 will be summarized as a percentage.
NVS Drug Plasma Concentrations
时间窗: Day 1 - 24 (Or Discharge)
The Peak Plasma Concentration (Cmax) will be determined from plasma 10-8-10 Dimer concentrations for blood samples collected.
次要结局
未报告次要终点