HORIZON. Clinical Investigation of the Qmedics EXIST NiTi Stent Type FLEX & PULL in Adults With Peripheral Artery Disease (PAD)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 69
- 试验地点
- 4
- 主要终点
- Primary patency
研究概览
简要总结
The objective of this clinical investigation is to demonstrate and provide long term clinical data on safety and performance of the Exist 6F NiTi stent system type FLEX & PULL in a prospective investigation for the treatment of adult patients with de novo or re-stenotic symptomatic atherosclerotic lesions in Peripheral Artery Disease (PAD) requiring treatment of the Superficial Femoral Artery (SFA) or Proximal Popliteal Artery (P1 segment).
详细描述
This is a multicenter, prospective study with clinical and radiographic follow-up for 24 months months post-procedure. Approximately two hundred thirty subjects will be enrolled (115 subjects will receive the FLEX type and 115 subjects the PULL type) in several centers, minimum 10 patients per investigational center. All patients will be evaluated at 30 days and 6-, 12- and 24-months post-index procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Clinical:
- •Patient age 18 years or older
- •Subject is willing and able to provide consent before any study specific test or procedure is performed, signs the consent form, and agrees to attend all required follow-up visits
- •Symptoms of peripheral arterial disease classified as Rutherford Category 2, 3 or 4 or Fontaine Class IIb or III
- •The stenotic or occlusive lesion in Superficial Femoral Artery (SFA) and proximal popliteal artery, P1 segment, is considered suitable for stenting
- •No underlying medical condition is present which would prevent the subject from performing the required testing or from completing the study.
- •Stable medical condition
- •Anatomical criteria:
- •Included TASC II, A-B-C measured on pre- angio CT-scan (if CT-scan is standard of care)
- •Lesions must be one or multiple that can be treated with maximum two stents, maximum one overlapping and maximum length of the stent 25 cm
- •Patent ipsilateral iliac, popliteal (P2 and P3) and at least one tibial vessel
排除标准
- •Clinical criteria:
- •Subjects pregnant, breastfeeding or planning to become pregnant during the trial participation
- •Documented life expectancy less than 24 months due to other medical co-morbid condition(s)
- •Thrombophlebitis or deep vein thrombosis within the past 30 days.
- •Unable to assume DAPT (Dual Antiplatelet Therapy)
- •Concomitant renal failure with serum creatinine level > 2.5 mg/dL (or > 220 µmol/L) or GFR < 30 ml/min/1,73 m2
- •Unresolved neutropenia (white blood cell count < 3,000 / µL) or thrombocytopenia (platelet count < 80,000 / µL) at the time of the index procedure
- •Unresolved bleeding disorder (INR ≥ 1.2) at the time of the index procedure
- •Active gastrointestinal bleeding
- •Anticoagulation therapy for other medical condition
- •Anatomical criteria:
- •Target lesion(s) received previous treatment within 30 days prior to enrolment (point of enrolment is defined as the time when the trial device enters the body)
- •Previously stented ipsilateral SFA
- •Prior peripheral vascular bypass surgery involving the target limb(s)
- •Target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion
- •Target lesion requires the use of cutting balloons, atherectomy or drug coated balloons (DCB) during the intervention
结局指标
主要结局
Primary patency
时间窗: 12 months
The primary patency rate (defined as freedom from more than ≥ 50% restenosis) at 12 months post-procedure as measured by Peak Systolic Velocity ratio (PSVr) assessed with Duplex ultrasound (DUS). A PSVr ≥ 2,5 suggests a reduction in the luminal diameter \>50%.
Major Adverse Events
时间窗: 1 month
Freedom from procedure- or stent-related Major Adverse Events (MAEs) at 30-days post index-procedure will be reported. MAE is defined as all causes of death and target limb major amputation, defined as amputation of the lower limb at the ankle level or above.
次要结局
- Improvement of Rutherford / Fontaine classification(6- and 12-months)
- Freedom from Target Lesion Revascularization(1 month, 6-, 12- and 24-months)
- Primary patency(12-months)
- Walking and mobility(1 month, 6-, 12- and 24-months)
- Patency rate(24 months)
- Major Adverse Events(24 months)
- Rate of stent fracture(12- and 24-months)