Prospective, Multicenter, Single Arm Safety and Effectiveness Trial of the Endologix Fenestrated Stent Graft System for the Endovascular Repair of Juxtarenal/Pararenal (JAA/PAA) Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 44
- 主要终点
- Safety- Number of Major Adverse Events at 30 Days
研究概览
简要总结
The purpose of this trial is to determine if the Ventana Fenestrated Stent Graft System is safe and effective for the endovascular repair of juxtarenal or pararenal aortic aneurysms.
详细描述
Study Objectives The objective of protocol CP-0004 is to study the safety and effectiveness of the Endologix Fenestrated System in the endovascular treatment of patients with juxtarenal and/or pararenal aortic aneurysms.
Study Design This clinical study is a prospective, non-randomized, multicenter study. The first patient enrolled at each site is designated as a 'Roll-In' group patient. Subsequently, enrolled patients are designated as 'Trial' group patients for primary endpoint analysis.
Primary Endpoint The primary safety endpoint is defined as the incidence of Major Adverse Events‡ (MAEs) within 30 days. The primary study effectiveness endpoint is Treatment Success at 1-year. This is defined as procedural technical success and the absence of aneurysm rupture; conversion to open surgical repair; Type I endoleak after 30 days; Type III endoleak; clinically significant migration; aneurysm enlargement; or secondary intervention for resolution of endoleak, limb occlusion, migration, aneurysm sac expansion and/or a device defect.
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
- •Male or female at least 18 years old;
- •Informed consent understood and signed and patient agrees to all follow-up visits;
- •Have aortic aneurysm with maximum diameter ≥5.5cm, or between 4.5 and 5.5cm and rapidly expanding (>0.5cm in six months), or >50% larger than the normal aortic diameter
- •Anatomically eligible for the Bifurcated System per the FDA-approved indications for use (IFU) and for the Fenestrated Stent Graft System:
- •Adequate iliac/femoral access compatible with the required delivery systems
- •Non-aneurysmal infrarenal aortic neck <15mm in length;
- •Most caudal renal artery to aortoiliac bifurcation length ≥70mm
- •SMA to aortoiliac bifurcation length ≥90mm;
- •Proximal non-aneurysmal aortic neck below the SMA with: diameter 18 to 34 mm; length ≥15 mm; angle ≤60° to the aneurysm sac;
- •Angle ≤60° (clock face) between the SMA and CA
- •Renal arteries both distal to the SMA by ≤35mm, within 30mm of each other axially, with 4 to 8mm lumen diameter, and with clock face angle of 90° to 210° to each other .Common iliac artery distal fixation site with: distal fixation length ≥15 mm; ability to preserve at least one hypogastric artery; diameter ≥10 mm and ≤23 mm; angle ≤90° to the aortic bifurcation.
- •The Endologix Fenestrated Proximal Extension Stent must have the ability to overlap the bifurcated stent graft by at least 3cm.
- •Aortic diameter at the most caudal renal artery of 18 to 36mm
排除标准
- •Life expectancy <2 years as judged by the investigator;
- •Psychiatric or other condition that may interfere with the study;
- •Participating in the enrollment or 30-day follow-up phase of another clinical study;
- •Known allergy to any device component;
- •Coagulopathy or uncontrolled bleeding disorder;
- •Contraindication to contrast media or anticoagulants;
- •Ruptured, leaking, or mycotic aneurysm;
- •Aortic dissection
- •Serum creatinine (S-Cr) level >2.0 mg/dL;
- •Traumatic vascular injury;
- •Active systemic or localized groin infection;
- •Connective tissue disease (e.g., Marfan's Syndrome);
- •Recent (within prior three months) cerebrovascular accident or myocardial infarction;
- •Prior renal transplant;
- •Length of either renal artery to be stented <13mm;
- •Significant occlusive disease of either renal artery (>70% stenosis);
- •An essential accessory renal artery;
- •Indispensable inferior mesenteric artery;
- •Aneurysmal disease of the descending thoracic aorta;
- •Clinically significant mural thrombus circumferentially in the suprarenal segment;
- •Prior iliac artery stent implanted that may interfere with delivery system introduction;
- •Unsuitable vascular anatomy;
- •Pregnancy (female patient of childbearing potential only)
- •Existing renal stent;
- •Pre-planned need for concomitant procedure (e.g. surgical conduit for vascular access, hypogastric artery embolization/coil, renal artery angioplasty)
结局指标
主要结局
Safety- Number of Major Adverse Events at 30 Days
时间窗: 30 Days
Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss \>1000cc
Effectiveness
时间窗: 1 Year
1. Treatment Success is defined as Procedural technical success and absence of aneurysm rupture, conversion to open repair, Type I endoleak after 30 days, Type III endoleak, clinically significant migration; aneurysm enlargement; or secondary intervention for resolution of endoleak, limb occlusion, migration, aneurysm sac expansion and/or a device defect. 2. Procedural Technical Success is defined as a subject with successful implant. 3. Clinically Significant Device Migration: Core Lab reported aortic stent graft movement \>10mm 4. Type I/III/IV Endoleak: Core Lab reported endoleak: between the endograft and the vessel either at the proximal attachment point (Type IA), or at the distal attachment point (Type IB), or between endograft components (Type III) or transgraft (Type IV). 5. Type II Endoleak: Core Lab reported endoleak emanating from a patent collateral vessel (e.g., inferior mesenteric artery, lumbar artery).
次要结局
- Time to Hospital Discharge(Hospital Discharge (Post-Procedure))
- Safety- Number of Major Adverse Events > 30 Days to 5 Years(>30 Days to 5 Years)
- Renal Dysfunction(Discharge to 5 Years)
- Time in ICU(In-Hospital)
- Device Integrity(30 Days to 5 Years)
- Aneurysm Sac Morphology(30 Days to 5 Years)
- Endoleaks(30 Days to 5 Years)
- Aneurysm Sac Diameter(30 Days to 5 Years)
- Device Patency(30 Days to 5 Years)
- Clinical Utility Outcomes(At the time of the procedure)