A Prospective, Multicenter, Non-Blinded, Non-Randomized Pivotal Study of the Fenestrated TREO Stent-Graft System in Subjects With Abdominal Aortic Aneurysms Requiring a Fenestrated Graft and Suitable for Endovascular Repair
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 7
- 主要终点
- Proportion of patients with successful aneurysm treatment through 12-months post-implant procedure (Primary Effectiveness Endpoint)
研究概览
简要总结
The goal of this clinical trial is to learn if the Fenestrated TREO Stent-Graft System works to treat abdominal aneurysms in adults. An abdominal aneurysm is a bulge in the main blood vessel (the aorta) which carries blood from the heart, through the chest and abdomen. It will also learn about the safety of Fenestrated TREO Stent-Graft System.
The main question it aims to answer is: Can the the Fenestrated TREO Stent-Graft System be used to treat participants with a specific type of abdominal aneurysm called a juxtarenal abdominal aortic aneurysm?
Participants will: Have the the Fenestrated TREO Stent-Graft System implanted via an endovascular surgical procedure and visit the hospital for a follow up period of 5 years, for checkups, tests and imaging scans.
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
- •18 years or older at the time of consent
- •Life expectancy is greater than 2 years
- •An abdominal aortic or aorto-iliac aneurysm requiring a fenestrated graft and with morphology suitable for endovascular repair (confirmed by Computed Tomography (CT) with contrast performed within 6 months of planned implant procedure) as follows:
- •Maximum aneurysm diameter of ≥5.5 cm for male ( ≥5.0 cm for female) or
- •Maximum AAA diameter exceeding two times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements (or saccular aneurysm that warrants treatment in the opinion of the investigator) or
- •Aneurysm with a history of growth > 0.5 cm in 6 months and
- •Minimum 0 mm of healthy aorta* below the most inferior renal artery that the physician plans on preserving and no renal artery involvement (juxtarenal aneurysms) or
- •At least one renal artery involved in the aneurysm and minimum 2 mm below the celiac (suprarenal aneurysms) *Healthy aorta is defined as segment of aorta with parallel aortic wall with minimal (<10%) or no difference in diameter and minimal atherosclerotic debris, thrombus, or calcification.
- •Proximal landing zone:
- •≥20 mm length
- •20-32 mm diameter
- •≤60° angle relative to the axis of the suprarenal aorta
- •≤60° angle relative to the long axis of the aneurysm
- •Distal (iliac) landing zone with:
- •8-13 mm inside diameter/ ≥10 mm length
- •>13-20 mm inside diameter/ ≥15 mm length
- •Distal aortic diameter (above the iliac bifurcation) ≥70% of the sum of the iliac limb graft diameters
- •Minimum 18 mm aortic lumen diameter at the level of the fenestrations
- •Pathology that requires maximum 5 fenestrations in the main body
- •Pathology that requires fenestration a minimum 3 mm apart (edge to edge)
- •Branch vessels (to be bridged to the fenestrated graft) with:
- •5-9 mm diameters
- •≥13 mm distal landing zone (or ≥15 mm if there is a gap between fenestration and target vessel)
- •Adequate renal function to tolerate contrast-enhanced CTA
- •Adequate vascular access compatible with required delivery systems
- •Willingness to comply with the follow-up evaluation schedule documented in a signed informed consent prior to implant
排除标准
- •Pregnant or lactating
- •Existing endovascular graft in the treated segment intended to be repaired with the Fenestrated TREO Stent-Graft System
- •Dissection in abdominal aorta, ruptured aneurysm, or symptomatic aneurysm (as determined by treating physician)
- •Implant procedure as planned does not allow for at least one patent hypogastric artery left intact, unless both are occluded on pre-op imaging.
- •A branch vessel(s) that is dissected or has significant calcification, tortuosity, thrombus formation that would interfere with bridging stent delivery or sealing (as determined by treating physician)
- •Severe untreated coronary artery disease and/or unstable angina, significant areas of myocardium at risk (based on coronary angiogram or radionuclide scans), left ventricular ejection fraction <20%, or recent diagnosis of congestive heart failure (CHF; as determined by treating physician).
- •Stroke or myocardial infarction within 6 months of the planned treatment date
- •Chronic obstructive pulmonary disease requiring routine need for oxygen therapy outside the hospital setting (e.g., daily or nightly home use)
- •Chronic Kidney Disease (CKD) stage ≥3b.*
- •* During Stage 2, patients with severe CKD (stage ≥3b) can be included in the Expanded Access Arm if otherwise eligible.
- •Active systemic infection or is suspected of having an active systemic infection (e.g., acquired immune deficiency syndrome (AIDS)/human immunodeficiency virus (HIV), sepsis)
- •Clinical conditions that would severely compromise or impair x-ray visualization of the aorta (as determined by treating physician).
- •History of an aortopathic connective tissue disease (e.g., Marfan's syndrome)
- •Mycotic aneurysm
- •Significant or circumferential calcification or mural thrombus (as determined by treating physician):
- •in the proximal aortic neck
- •in the distal iliac landing zone
- •within the treatment length, which may adversely impact device patency
- •Cannot receive intraprocedural anticoagulation per the investigator's standard of care, or antiplatelet therapy post-procedurally as per the investigator's standard of care.
- •Blood coagulation disorder or bleeding diathesis, the treatment for which cannot be suspended pre- and post-repair
- •An investigational study drug or biologic within 30 days of planned procedure or an investigational device within one year of planned procedure or any other treatment that may interfere with the interpretation of the study results.
- •Medical, social or psychological issues that the investigator believes may interfere with study treatment or follow-up.
- •Untreatable allergy or sensitivity to contrast media, nitinol/nickel, Tantalum, Platinum Iridium (PtIr), 316 stainless steel, ePTFE (expanded polytetrafluoroethylene), PTFE (polytetrafluoroethylene) Impregnated polyester fiber, or polyester
- •Other major surgical or medical intervention within 45 days of the planned procedure or plan to undergo other major surgical or medical intervention within 45 days post implantation (e.g., coronary artery bypass graft (CABG), organ transplantation, renal stenting)
研究组 & 干预措施
Stage 1 - Roll-in Arm
Minimum of 20 subjects (up to 30) with juxtarenal Abdominal Aortic Aneurysm (AAA), being treated with the Fenestrated TREO Stent-Graft System
干预措施: Fenestrated TREO Stent Graft System (Device)
结局指标
主要结局
Proportion of patients with successful aneurysm treatment through 12-months post-implant procedure (Primary Effectiveness Endpoint)
时间窗: 12 months post-procedure
The primary effectiveness endpoint is the proportion of patients with successful aneurysm treatment through 12-months post-implant procedure, which is a composite of technical success and absence of the following: * Aneurysm-related mortality: Death occurs within the first 30-days of the index procedure or a secondary intervention, OR any death that results from aneurysm rupture or an aorta-related complication (e.g., implant infection, occlusion, dissection) * Aneurysm rupture: Rupture of the native aneurysm sac (treated lesion) * Type I/III Endoleak * Aneurysm Expansion (\>5 mm) * Migration (\>10 mm) * Loss of patency (i.e., complete occlusion of the aortic implant and/or bridging stent(s)) * Conversion to open surgical repair: Explant of the investigational device due to any cause * Secondary intervention (clinically significant) to address loss of patency, fixation or seal
Successful delivery and deployment of the aortic stent-graft and all modular stent-graft components (Technical Success)
时间窗: Evaluated 30-days post procedure
Composite: * Successful access to the arterial system using remote arterial exposure, percutaneous technique, or open surgical conduit without the need for unanticipated corrective intervention related to access * Successful delivery and deployment of the aortic stent-graft and all modular stent-graft components without the need for unanticipated corrective intervention related to delivery and deployment * Successful side branch catheterization and placement of bridging stents with restoration and maintenance of flow in all intended target vessels without the need for unanticipated corrective intervention related to placement of the bridging stent(s) * Successful withdrawal of the delivery systems without the need for unanticipated corrective intervention related to withdrawal * Absence of Type I or III endoleaks (assessed by Computed Tomography Angiography, Magnetic Resonance Angiography, or duplex ultrasound) * Patency of all aortic modular stent graft components
Proportion of patients with absence of a major adverse event (Primary Safety Endpoint)
时间窗: 30-day post-procedure
The primary safety endpoint is the absence of a major adverse event (MAE) at 30-day post procedure. MAEs are defined as follows: * All-cause mortality, defined as death due to any cause * Myocardial infarction (new onset) based on the Society for Cardiovascular Angiography \& Interventions (SCAI) definition * Respiratory failure requiring prolonged (\>24 hours from anticipated) mechanical ventilation or reintubation * Renal function decline resulting in \>50% reduction from baseline estimated glomerular filtration rate (eGFR) or new-onset dialysis * Bowel ischemia requiring surgical resection or not resolving with medical therapy * Disabling stroke (modified Rankin Scale (mRS) score ≥2 at 90 days post event and an increase in ≥1 mRS category from an individual's pre-stroke baseline, as direct result of the neurological event) * Paraplegia (grade 3, Society for Vascular Surgery (SVS) Thoracic Endovascular Aortic Repair (TEVAR) guidelines)
次要结局
- All-Cause Mortality(Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.)
- Myocardial Infarction (new onset)(Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.)
- Respiratory failure(Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.)
- Renal function decline(Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.)
- Bowel ischemia(Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.)
- Disabling stroke(Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.)
- Paraplegia(Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.)
- Aneurysm-related mortality(Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.)
- Aneurysm rupture(Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.)
- Type I/III Endoleak(Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.)
- Aneurysm Expansion(Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.)
- Loss of device patency(Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.)
- Conversion to open surgical repair(Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.)
- Secondary intervention (clinically significant) to address loss of patency, fixation or seal(Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.)
- Technical Success (at the index procedure)(At time of index procedure)
- Presence of endoleak(Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.)
- Aneurysm size changes(Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.)
- Patency related observations(Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.)
- Loss of device integrity(Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.)
- Target vessel instability(Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.)
- Secondary interventions related to the device/treated lesion(Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.)
- Target vessel complications(Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.)
- Access-related complications(Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.)
- Serious Adverse Events(Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.)
- Operative metrics - Number of Vessels intended to be Perfused via Fenestrated TREO Fenestrations(Evaluated at time of implant)
- Operative metrics - Mechanism of access(Evaluated at time of implant)
- Radiation Exposure - Fluoroscopy Time(Evaluated at time of implant)
- Radiation Exposure - Total volume of Contrast(Evaluated at time of implant)
- Device Migration(Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.)
- Device Migration Evaluation(Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.)
- Operative metrics - Time(Perioperative)