Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System (INFINITE-US)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 9
- 主要终点
- Change in Revised Venous Clinical Severity Score (rVCSS) From Baseline
研究概览
简要总结
Prospective, non-randomized, multicenter pre-market early feasibility study (EFS) to evaluate subjects treated with the BlueLeaf System for the treatment of symptomatic chronic venous insufficiency (CVI) of the lower extremity
详细描述
The purpose of this early feasibility study is to provide information on the BlueLeaf System for the formation of one or more autogenous vein valves constructed from the vein wall of the femoral and/or popliteal vein, in subjects with CVI and who meet the specified eligibility criteria. In particular, the safety and technical feasibility of the procedure will be validated in patients in the United States, including the procedural steps, operator technique, and subject characteristics. The study will assess the safety and effectiveness of the study device acutely and through 5 years.
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
- 未提供
排除标准
- •Untreated significant superficial venous incompetence which, in the opinion of the Investigator, may be the primary source of existing symptoms
- •Acute deep venous thrombosis (DVT) within 1 year of consent
- •Deep venous intervention (includes stenting) in the target limb or outflow vessels within 3 months of consent
- •Flow-limiting venous outflow obstruction central to the intended target sites, defined by a common femoral vein duplex exam found to have a continuous waveform without respiratory variation
- •Contraindications to all protocol specified anticoagulation options
- •Known and uncontrolled hypercoagulopathy (i.e. hypercoagulopathy that cannot be adequately managed/controlled with medication)
- •Women on long-term oral contraceptives
- •Non-ambulatory patients
- •Significant peripheral arterial disease with an ankle-brachial index of < 0.70 or with incompressible vessels
- •New York Heart Association Class III or IV heart failure
- •Patients with a history of right heart failure occurring as a consequence of, for example, biventricular failure, intrinsic pulmonary disease, chronic thromboembolic pulmonary hypertension, and other etiologies that result in elevated right-sided pressures.
- •Active systemic infection
- •Invasive surgical procedure within the last 3 months that in the Investigator's opinion would interfere with the study procedure or results
- •Chronic renal insufficiency with creatinine level of ≥ 2mg/dL
- •Hemoglobin level < 9.0 mg/dL
- •Platelet count < 50,000 or > 1,000,000/mm3
- •Total white blood cell count < 3,000/mm3
- •Subject is enrolled in another clinical study that, in the opinion of the Investigator, may conflict with this study or compromise study results
- •Comorbidity risks or other concerns which, in the opinion of the Investigator, either limits longevity or likelihood of complying with the protocol and its prescribed follow up (e.g. recent cancer or stroke); or precludes patient from being transitioned to open surgery if complication requiring surgical intervention occurs during the procedure (such as severe vein laceration).
结局指标
主要结局
Change in Revised Venous Clinical Severity Score (rVCSS) From Baseline
时间窗: Baseline, 30-days, 12-weeks, 210-days and 365-days post-procedure
Assessment of changes in the rVCSS; the score is a composite based on a rating score of none (0), mild (1), moderate (2) and severe (3) for symptoms and clinical signs, the number of active ulcers (0, 1, 2, \>/=3), duration of ulcers (\<3 months, \>3 months but \<1 year, not healed for \>1 year), active ulcer size (diameter \<2cm, diameter 2-6cm, and diameter \>6cm), and use of compression therapy (not used (0), intermittent use of stockings (1), wears stockings most days (2), and full compliance (3)). A higher VCSS would indicate a worse outcome.
Primary Safety Endpoint: The Number of Subjects Experiencing a Major Adverse Event (MAE), Composed of the Following
时间窗: 30-day post-procedure
* Symptomatic pulmonary embolism * DVT anywhere in the deep venous system of the treatment limb * Occlusive valve pocket thrombus (VPT) * Non-occlusive stenosis in the target vessel (including due to scarring, inflammation, VPT, etc.) leading to persistent worsening of symptoms attributable to venous flow obstruction, or requiring post-procedural surgical or endovascular re-intervention * Device or procedure-related venous or arterial injury in the treated limb (such as Arteriovenous Fistula (AVF's), bleeding, pseudo aneurysm) leading to worsening of symptoms that require post-procedural surgical or endovascular re-intervention or requiring transfusion of more than 2 units of blood. (Note: Peri-procedural stiches placed to assist with closure of the access site will not be characterized as a primary safety failure.) * Device or procedure-related death
次要结局
未报告次要终点