Single-Center Investigational Device Exemption Trial: Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Technical success
研究概览
简要总结
The primary objective of this study is to examine the safety and effectiveness of physician-modified endovascular grafts (PMEGs) for endovascular repair of complex aortic pathology in high-risk patients. The study is divided into three study arms based on the subject's aortic pathology: (1) Complex abdominal aortic aneurysm (AAA); (2) Thoracoabdominal aortic aneurysm; and (3) Aortic dissection.
详细描述
Complex aortic pathology, comprised of aneurysmal disease and aortic dissection involving the visceral aortic segment, presents a technical challenge for repair due to involvement of the renal and/or mesenteric arteries. Traditionally, the gold standard for repair has been open repair. However, open repair of these diseases is associated with high perioperative morbidity and mortality. Therefore, for patients with significant medical comorbidities or complex surgical/anatomical features, the risk of open surgery may be prohibitive.
As endovascular techniques have become increasingly advanced, options for the endovascular treatment of complex aortic pathology involving the visceral segment have been developed. The predominant approach is fenestrated or branched endovascular aortic repair (F/B-EVAR) with fenestrated or branched endovascular grafts. Currently, there is only one device FDA-approved for commercial use in the United States, the Zenith Fenestrated AAA Endovascular Graft (Cook Medical, Bloomington, IN). However, its use is limited by the design specifications of the device and the required manufacturing time in patients requiring more urgent repair. Therefore, many patients with complex aortic pathology are not eligible for repair with this device, and there are currently no other FDA-approved options for definitive repair.
One option for definitive repair of complex aortic pathology in patients ineligible for the Zenith fenestrated device is endovascular repair with a physician-modified endovascular graft (PMEG). For this procedure, the operating surgeon modifies an FDA-approved endovascular graft to incorporate fenestrations or branches based on the patient's anatomy. Numerous reports have been published demonstrating that this procedure can be performed with high technical success, and acceptable perioperative and mid-term results in high-risk patients.
The primary objective of the study is to evaluate safety and effectiveness of PMEGs for the endovascular repair of complex aortic pathology in high-risk patients. The safety outcomes include perioperative mortality (defined as death <30 days postoperative or during the index hospitalization) and major adverse events, along with mortality and adverse events during follow-up. Effectiveness outcomes include initial technical success, endoleak rate, target vessel patency, and rate of reintervention. Patients will be followed for five years. Patients will be evaluated preoperatively, at the time of the procedure, at the time of discharge from the index hospitalization, 1-month post-procedure, 6-months post-procedure, and 1-year post-procedure, and annually for five-years.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General inclusion criteria (applicable to all 3 study arms):
- •Aortic pathology that fits one of the study arms (see below for detailed description)
- •Aortic pathology that cannot be treated within the Instructions for Use of an FDA- approved, commercially-available device
- •Aortic aneurysm that can be treated within the Instructions for Use of an FDA-approved, commercially-available custom-manufactured device but deemed unsafe to wait the required time for device manufacturing
- •Subject is at high-risk of morbidity and mortality with open surgical repair based on cardiopulmonary function, extent of comorbid disease, and anatomic complexity
- •Iliac and/or femoral access vessel morphology that is compatible with vascular access techniques, devices, or accessories, with or without use of a surgical or endovascular conduit
- •Non-aneurysmal aortic segment proximal to the aortic pathology with a:
- •Minimum neck length of 20 mm
- •Diameter between 20 - 42 mm
- •Non-aneurysmal aortic or iliac segment distal to the aortic pathology with:
- •Aortic distal fixation site greater than 20 mm in length and diameter between 20-42 mm
- •Iliac artery distal fixation site greater than 10 mm in length and diameter range 8- 25 mm
- •Age ≥21 years old
- •Life expectancy: ≥2 years
- •Complex abdominal aortic aneurysm, specifically juxtarenal or suprarenal abdominal aortic aneurysm or type IV thoracoabdominal aortic aneurysm, with maximum diameter of ≥5.5 cm for men or ≥5.0 cm for women, growth ≥0.5 cm in 6 months, or concomitant iliac aneurysm ≥3 cm
- •Prior endovascular aortic aneurysm repair with loss of proximal seal requiring incorporation of the renal arteries, SMA, and/or CA for repair, without aneurysmal disease extending above the diaphragmatic hiatus
- •Prior open abdominal aortic aneurysm repair with aneurysmal disease proximal to the repair requiring incorporation of the renal arteries, SMA, and/or CA for repair, without aneurysmal disease above the diaphragmatic hiatus
- •Saccular complex abdominal aortic aneurysm deemed at significant risk for rupture
- •Symptomatic complex aortic aneurysm
- •Penetrating aortic ulcer with depth ≥1 cm or width ≥2 cm, for which endovascular repair requires incorporation of the renal arteries, SMA, and/or CA, without involvement of the aorta above the diaphragmatic hiatus
- •Aortic pseudoaneurysm for which endovascular repair requires incorporation of the renal arteries, SMA, and/or CA, without involvement of the aorta above the diaphragmatic hiatus
- •Type I, II, or III thoracoabdominal aortic aneurysm with maximum diameter of ≥5.5 cm, or growth ≥0.5 cm in 6 months
- •Prior endovascular aortic aneurysm repair with loss of proximal seal requiring incorporation of the renal arteries, SMA, and/or CA for repair with aneurysmal disease extending above the diaphragmatic hiatus
- •Prior thoracic endovascular aneurysm repair with loss of distal seal requiring incorporation of the renal arteries, SMA, and/or CA for repair
- •Prior open abdominal aortic aneurysm repair with aneurysmal disease proximal to the repair requiring incorporation of the renal arteries, SMA, and/or CA for repair, with aneurysmal disease above the diaphragmatic hiatus
- •Saccular type I, II, or III thoracoabdominal aortic aneurysm deemed at significant risk for rupture
- •Symptomatic type I, II, or III thoracoabdominal aortic aneurysm
- •Penetrating aortic ulcer with depth ≥1 cm or width ≥2 cm, for which endovascular repair requires incorporation of the renal arteries, SMA, and/or CA, with involvement of the aorta above the diaphragmatic hiatus
- •Aortic pseudoaneurysm for which endovascular repair requires incorporation of the renal arteries, SMA, and/or CA, with involvement of the aorta above the diaphragmatic hiatus
- •Acute or chronic type B aortic dissection with indication for repair including, but not limited to renal, mesenteric, or lower extremity malperfusion, progression of dissection, or persistence of symptoms despite optimal medical therapy
- •Prior repair of type A dissection and development of acute or chronic type B dissection component with indication for repair (listed above)
- •Aortic intramural hematoma (IMH) with indication for repair including, but not limited to renal, mesenteric, or lower extremity malperfusion, progression of dissection, or more typically, persistence of symptoms despite optimal medical therapy
- •Patient does not meet the inclusion/
排除标准
- •of Arms 1 - 3
- •Patient has prohibitive operative risk for open repair and no other viable endovascular treatment option
- •Estimated perioperative risk is lower than the estimated 1-year mortality without surgery
- •EXCLUSION CRITERIA:
- •General Exclusion Criteria
- •Subject is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site
- •Subject is unwilling to comply with the follow-up schedule
- •Inability or refusal to give informed consent by subject or legal representative
- •Subject is pregnant or breastfeeding
- •Subject has a ruptured aneurysm
- •Arm 5 • Patient meets criteria for Arms 1-4
- •- Patient is undergoing repair using the TREO bifurcated stent graft
- •Indications for using TREO bifurcated stent graft:
- •Patient has undergone a prior endovascular aortic repair and meets criteria for repair; OR
- •-Patient has measured length from the lowest renal artery to the aortic bifurcation (either de novo or from a prior endograft) < 115 mm; OR
- •In patients with notable vessel tortuosity, where centerline measurement may not accurately reflect the distance covered needed in situ; OR
- •Additional clinical or anatomic scenarios where forthcoming experience may demonstrate the TREO endograft to be superior to the currently-used Alpha/Alpha 2 endograft.
- •Medical Exclusion Criteria
- •Known sensitivities or allergies to the materials of construction of the devices
- •Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed
- •Uncorrectable coagulopathy
- •Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment
- •Systemic or local infection that may increase the risk of endovascular graft infection
- •Diagnosis of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome)
- •Anatomic Exclusion Criteria
- •Inability to perform open or endovascular iliac conduit in patients with inadequate femoral/iliac access
- •Excessive thrombus or calcification within the neck of the aneurysm
- •Visceral vessel anatomy not compatible with placement of a physician-modified endovascular graft due to occlusive disease or small size
研究组 & 干预措施
Complex abdominal aortic aneurysm (AAA)
Includes juxtarenal AAA, suprarenal AAA, and type IV thoracoabdominal aortic aneurysm
干预措施: Endovascular aortic repair with a physician-modified endovascular graft (PMEG) (Device)
Thoracoabdominal aortic aneurysm (TAAA)
Includes Type I, Type II, and Type III TAAA
干预措施: Endovascular aortic repair with a physician-modified endovascular graft (PMEG) (Device)
Type B aortic dissection
Includes all Type B dissections
干预措施: Endovascular aortic repair with a physician-modified endovascular graft (PMEG) (Device)
Expanded Selection Arm
Includes high risk subjects who do not meet inclusion criteria for Arms 1-3
干预措施: Endovascular aortic repair with a physician-modified endovascular graft (PMEG) (Device)
Expanded Treatment
Includes subjects who will have the PMEG TREO graft
干预措施: TREO graft (Device)
结局指标
主要结局
Technical success
时间窗: 24 hours
Defined as successful delivery of the physician-modified graft in the planned location with patency of all intended target vessels and without unintentional coverage of any aortic branches, along with successful removal of the delivery system
Aneurysm rupture
时间窗: 30-days to 5-years
Rate of aneurysm rupture at: 30-days, 6-months, 1-year, and annually to 5-years
Long-term major adverse events
时间窗: 6-months to 5-years
Rate of major adverse events at: 6-months, 1-year, and annually to 5-years Long-term major adverse event is defined as having at least one of the following: * Death * Stroke (deemed related to the device, the procedure, or a reintervention) * Bowel ischemia requiring treatment (deemed related to the device, the procedure, or a reintervention) * Renal failure requiring dialysis (deemed related to the device, the procedure, reintervention, or follow-up imaging) * Acute limb ischemia (deemed related to the device, the procedure, or a reintervention)
Perioperative major adverse events
时间窗: Up to 30-days after surgery
Rates of: * Stroke * Respiratory failure (defined as postoperative intubation \>48 hours or reintubation) * Myocardial infarction * Bowel ischemia requiring treatment * Renal failure requiring dialysis * Acute limb ischemia * Paraplegia
Aneurysm-related mortality
时间窗: 30-days to 5-years
Rate of aneurysm-related death at: 30-days, 6-months, 1-year, and annually to 5-years
Device-related reintervention
时间窗: 30-days to 5-years
Rate of device-related reintervention at: 30-days, 6-months, 1-year, and annually to 5-years
Residual aneurysm sac status
时间窗: 6-months, 1-year, and annually to 5-years
Rate of residual sac status (stable, regressing, expanding) at 6-months, 1-year, and annually to 5-years, defined as the following: * Stable: maximum diameter within 5 mm of the diameter at 30-day follow-up * Regressing: maximum diameter ≥5 mm less than the diameter at 30-day follow-up * Expanding: maximum diameter ≥5 mm greater than the diameter at 30-day follow-up
All-cause mortality
时间窗: 30-days to 5-years
Rate of death due to any cause at: 30-days, 6-months, 1-year, and annually to 5-years
Conversion to open repair
时间窗: 30-days to 5-years
Rate of conversion to open repair at: 30-days, 6-months, 1-year, and annually to 5-years
Endoleaks
时间窗: 30-days to 5-years
Rate of Type I, II, III, IV, and V endoleaks at: 30-days, 6-months, 1-year, and annually to 5-years
Main device occlusion
时间窗: 30-days to 5-years
Rate of main device occlusion at: 30-days, 6-months, 1-year, and annually to 5-years
Perioperative mortality
时间窗: Up to 30-days after surgery
Rate of death
Target vessel patency
时间窗: 30-days to 5-years
Rate of target vessel patency at: 30-days, 6-months, 1-year, and annually to 5-years
次要结局
未报告次要终点
研究者
Marc L. Schermerhorn, MD
Chief, Vascular and Endovascular Surgery
Beth Israel Deaconess Medical Center