Endologix Bifurcated PowerLink System Clinical Study
试验速览
- 阶段
- 2 期
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Mortality Rate
研究概览
简要总结
The Bifurcated PowerLink System is intended to provide a permanent alternative conduit for blood flow within a patient's abdominal vascular system, which excludes the aneurysmal sac from blood flow and pressure.
详细描述
An arterial anuerysm is a permanent, localized dilatation of an artery with an increase in diameter ≥ 50% larger than the normal artery. Although any artery may develop an aneurysm, they are most commonly seen in the abdominal aorta, the thoracic aorta, the popliteal artery and the common iliac artery.
The use of intravascular stents and endoluminal grafts to exclude natural arterial aneurysms or treat occlusive vascular lesions has been evaluated in a number of preclinical studies. Endovascular stent graft implantation obviates the need for abdominal surgery by using the peripheral arteries as a route to the aneurysm, and stents provide a means of graft attachment other than sutures. The goal of endoluminal grafting is the same as that of conventional repair and allows insertion of a resilient conduit between the ends of the aneurysm to exclude it from the circulation and prevent rupture of the aneurysm.
This is a Phase 2 Clinical Study of the Bifurcated PowerLink System (Endoluminal Graft) for the treatment of abdominal infrarenal aorto-iliac aneurysmal disease (AAA). Diagnostic imaging methods such as Spiral CT Scans, angiography, ultrasound and fluoroscopy imaging will be used to choose the sites for placement of the device and to assure precise deployment.
The Delivery Catheter allows endovascular placement of the Device (endoluminal graft) via either retrograde (femoral or iliac arteries) or antegrade (brachial arteries) approaches. The Endoluminal Graft (ELG) is a self-expanding metal alloy stent cage, which is covered on the outside by a thin walled ePTPE graft material. The graft material is fully supported throughout the entire ELG length. The ELG is also available in a bifurcated configuration. The bifurcated delivery catheter is available in various diameters and working lengths. The catheter consists of an introducer sheath with homeostatic vavle and an inner shaft. The inner shaft is an obturator with a tapered tip connected to a rear obturator by means of a hypotube. The main body of the ELG is compressed around the hypotube then loaded into the Delivery Catheter. The contralateral and ipsilateral limbs of the ELG are compressed in their respective limb covers and loaded into the Delivery Catheter. The inner shaft accommodates a standard .035 inch guidewire.
The concurrent surgical control and test patients' participation in the Study will include enrollment, the Investigational Device procedure or surgical repair and follow-up period. Patient data will be collected during: pre-operative, operative and post-operative follow-up at discharge and at 1 month. Long term follow-up for both the concurrent surgical controls and test patients will continue for 6 and 12 months to support a PMA. Extended follow-up may be required until the Investigational Device is approved under a PMA, or up to 5 years follow-up under Post Market Surveillance requirements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •≥ 18 years old
- •Informed consent understood and signed
- •Will comply with post-treatment follow-up requirements
- •Candidate for conventional open surgical repair
- •Anatomic Inclusion Criteria:
- •Aneurysm is ≥ 4.0 cm in outer diameter or Saccular aneurysm ≥ 3.0 cm in outer diameter or Aneurysm ≥ twice the normal aortic outer diameter or rapidly growing aneurysm (≥ 5 mm over 6 months)
排除标准
- •Life expectancy < 2 years
- •Participating in another clincal research study
- •Pregnant or lactating women
- •Acutely ruptured or leaking aneurysm, or vascular injury due to trauma
- •Patient has other medical or psychiatric problems, which in the opinion of the Investigator, precludes them from participating in the Study.
- •Contrast medium or anticoagulation drugs are contraindicated
- •Coagulopathy or bleeding disorder
- •Active systemic or localized groin infection
- •Inferior mesenteric artery is indispensable
- •Connective tissue disease (e.g. Marfan's Syndrome)
- •Creatinine level > 1.7 mg/dl
- •Thrombus at implantation sites
结局指标
主要结局
Mortality Rate
时间窗: one year
Major complications: myocardial infarction, coronary intervention, respiratory failure, aneurysm rupture, kidney failure, stroke or death
时间窗: one year
次要结局
- Delivery and stent graft deployment success(1 month, 6 month, and 12 months)
- Stent graft patency, occlusion (non-patency) and migration(1 month, 6 month, and 12 months)
- Apposition to the vessel wall(1 month, 6 month, and 12 months)
- Duration of surgical procedure and hospitalization(1 month, 6 month, and 12 months)
- Device Integrity(1 month, 6 month, and 12 months)
- Time spent in the ICU(1 month, 6 month, and 12 months)
- Amount of blood loss and number of patients requiring blood transfusion with stored blood(1 month, 6 month, and 12 months)