AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
- 试验地点
- 95
- 主要终点
- Primary Safety Endpoint : Major Adverse Event (MAE) Rate through 30 days
研究概览
简要总结
To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to on-label endovascular aneurysm repair (EVAR) stent graft treatment in trial subjects considered candidates for elective EVAR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Subjects will be blinded to the treatment arm prior to the index procedure; after the procedure, they will be unblinded prior to discharge to prevent unintentional unblinding due to imaging
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 of age
- •A candidate for elective EVAR of an infrarenal fusiform aortic aneurysm ≥5.5 cm in diameter in men and ≥5.0 cm in women;
- •Thrombus burden (percentage of the AAA sac occupied by thrombus) <50%, based on pre-procedure CTA
- •Maximum Lumen diameter within the AAA sac of ≥40mm.
- •The predicted minimum number of IMPEDE-FX RapidFill Implants for the subject is ≤200.
排除标准
- •An inability to provide informed consent.
- •Enrolled in another clinical study that could interfere with the outcomes being studied in this trial.
- •Unable or unwilling to comply with study follow-up requirements.
- •Prisoner or member of other vulnerable population
- •Concomitant iliac artery ectasia or aneurysm
- •Vascular disease and/or anatomy that preclude the safe access and positioning of a catheter to deliver the investigational product into the AAA sac.
- •Ruptured, leaking, inflammatory or mycotic (infected) aneurysm.
- •Connective tissue disorder (e.g., Marfan's syndrome)
- •Aneurysmal disease of the descending thoracic aorta
- •Excessive calcification at the aortic bifurcation to common/internal iliac bifurcation, that might lead to access difficulties
- •EVAR/Procedural
- •Use of aortic stent grafts other than the Gore Excluder AAA Endoprosthesis, Gore Excluder Conformable AAA Endoprosthesis, Cook Zenith Flex AAA Endovascular Graft, Medtronic Endurant II and Endurant IIs Stent Graft, or the Terumo TREO Stent Graft to treat the AAA
- •Use of an aortic stent graft other than those specified1 for a particular site
- •Planned use of the chosen stent graft outside its instructions for use (IFU)
- •Use of fenestrated stent grafts or chimney techniques
- •Use of the Heli-FX EndoAnchor system
- •Use of embolic devices other than the investigational product to embolize the AAA sac
- •Use of embolic products to prophylactically or concomitantly embolize the inferior mesenteric artery, lumbar arteries, renal accessory arteries, or internal iliac arteries
- •Inability to land the distal-most portion of the EVAR stent graft limbs, including extensions, above the internal iliac arteries
- •Medical History/Conditions
- •Coagulopathy or uncontrolled bleeding disorder
- •Serum creatinine level >2.5 mg/dL
- •Cerebrovascular accident within 3 months prior to the procedure
- •Myocardial infarction and/or major heart surgery within 3 months prior to the procedure
- •Atrial fibrillation that is not well rate controlled
- •Life expectancy of <2 years post-procedure
- •Known hypersensitivity or contraindication to platinum, iridium, or polyurethane.
- •Have active infection at the time of the index procedure documented by pain, fever, drainage, positive culture, or leukocytosis (WBC >11,000/mm3)
- •A condition that inhibits radiographic visualization during the implantation procedure
- •History of allergy to contrast medium that cannot be managed medically, or subject is unable to have a CT with contrast for any reason.
- •Uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the trial
- •Pregnant or lactating female: for females of child-bearing potential, based on a positive pregnancy test within 7 days prior to the procedure or refusal to use a medically accepted method of birth control for the duration of the trial
研究组 & 干预措施
Treatment
Treatment Arm: Subjects in the treatment arm will have both an EVAR device and IMPEDE-FX RapidFill implants inserted.
干预措施: IMPEDE-FX RapidFill Implants (Device)
Treatment
Treatment Arm: Subjects in the treatment arm will have both an EVAR device and IMPEDE-FX RapidFill implants inserted.
干预措施: EndoVascular Aneurysm Repair (Procedure)
Control
Control Arm: Subjects in the control arm will only have an EVAR device implanted.
干预措施: EndoVascular Aneurysm Repair (Procedure)
结局指标
主要结局
Primary Safety Endpoint : Major Adverse Event (MAE) Rate through 30 days
时间窗: 30 days
Freedom from the following through 30 days post-index procedure: * Major adverse events (MAEs) which include the following: all-cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, procedural blood loss \>1000 mL. * AAA-rupture or AAA-perforation * Conversion to Open Repair
Primary Effectiveness Endpoint : AAA Sac Regression at 1 year
时间窗: 1 year
The percentage of subjects showing regression, defined as sac volume reduction of ≥10% at 1 year (in comparison to the 30 day CT), and no AAA-related intervention through 1 year.
次要结局
未报告次要终点