NCT02323581招募中不适用
Feasibility, Safety, and Clinical Outcomes of Endovascular Treatment of Thoracoabdominal Aortic Aneurysms and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts
Darren Schneider, M.D.4 个研究点 分布在 1 个国家目标入组 520 人开始时间: 2013年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 520
- 试验地点
- 4
- 主要终点
- Technical Success
研究概览
简要总结
Prospective, nonrandomized, single-center, two-arm study to assess the feasibility and safety and to evaluate clinical outcomes of endovascular repair of complex aortic aneurysms (thoracoabdominal aortic aneurysms and aortic arch aneurysms) in patients at high risk for open surgery.
详细描述
To assess the feasibility and safety and to evaluate clinical outcomes of endovascular repair of complex aortic aneurysms (thoracoabdominal aortic aneurysms and aortic arch aneurysms) in patients at high risk for open surgery in two study arms:
- TAAA (thoracoabdominal aortic aneurysm) Study Arm: To assess the feasibility and safety and to evaluate clinical outcomes of endovascular stent graft implantation using either a multibranched stent graft (Off-the-Shelf TAAA Device) or custom-manufactured physician-specified branched and/or fenestrated stent graft (Physician-Specified TAAA Device) to treat aortic aneurysms involving the mesenteric and/or renal arteries (TAAA) in patients at high risk for open surgery.
- Aortic Arch Study Arm: To assess the feasibility and safety and to evaluate clinical outcomes of endovascular stent graft implantation using 1) physician-specified aortic arch stent graft device with up to 3 antegrade and/or retrograde branches or 2) a physician-specified retrograde left subclavian branch stent-graft with double or triple wide scallop to the left common carotid artery] to treat aortic aneurysms involving the aortic arch in patients at high risk for open surgery.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of TAAA in:
- •Men with TAAA greater than or equal to 6 cm in diameter
- •Women with TAAA greater than or equal to 5 cm in diameter
- •Men with TAAA larger than 5 cm in diameter and enlarging at a rate of more than 10mm/year
- •Women with TAAA larger than 4.5 cm in diameter and enlarging at a rate of more than 10mm/year or
- •Men or women with TAAA and an iliac artery aneurysm greater than or equal to 4 cm in diameter
- •Life expectancy more than 2 years
- •Ability to give informed consent, complete pre-treatment assessments and comply with the follow-up schedule per protocol
- •Suitable arterial anatomy for endovascular TAAA repair with "TAAA device":
- •Proximal aortic landing zone:
- •≥ 20mm long
- •≤ 40mm and ≥ 20mm diameter in parallel aorta
- •free from circumferential thrombus
- •≤ 60 degrees angulation
- •Mesenteric/renal aortic diameter ≥ 20mm
- •Mesenteric arteries:
- •≥ 10mm long segment of healthy artery for branch attachment
- •Diameter ≥ 4mm and ≤ 12mm
- •Absence of aberrant or early branching, aneurysm or dissection
- •Renal arteries:
- •≥ 10mm long segment of healthy artery for branch attachment
- •Diameter ≥ 4mm and ≤ 8mm
- •Absence of aberrant or early branching, aneurysm or dissection
- •Iliac artery access:
- •≥ 6mm diameter, and absence of severe calcification and tortuosity
- •Or, planned creation of surgical conduit for TAAA device delivery
- •For patients with associated common iliac artery aneurysms (>20mm diameter), adequate internal and external iliac artery landing zones and common iliac artery luminal diameter (for iliac branch device use):
- •≥ 10mm long segment of healthy internal iliac artery for branch attachment
- •Internal iliac diameter ≥ 5mm and ≤ 12mm
- •External iliac diameter ≥ 6mm diameter, and absence of severe calcification and tortuosity
- •Minimum common iliac artery luminal diameter ≥ 14mm
- •Or, in patients with bilateral common iliac artery aneurysms without suitable anatomy, planned surgical bypass to maintain patency of at least one internal iliac artery
- •Patients deemed high risk for open repair (meeting one, or more, of the following criteria):
- •Age ≥ 65 year
- •Cardiac disease:
- •CAD (history of MI or angina with positive stress test and not revascularizable)
- •LV Ejection fraction < 40%
- •Symptomatic CHF (NYHC Class II, III, or IV)
- •Pulmonary disease:
- •Home oxygen therapy
- •FEV1 < 1.2 l/s
- •Vital capacity < 50% predicted
- •PaCO2 > 45 mm Hg or < 60 mm Hg
- •Renal disease:
- •ESRD on dialysis
- •eGFR < 60
- •Prior aortic surgery
- •Hostile abdomen
- •Portal hypertension (ascites or varices)
- •Coagulopathy
- 另有 57 项未显示
排除标准
- •Rupture, with hypotension (systolic bp < 90).
- •Pregnancy or breastfeeding.
- •Unwillingness or inability to comply with the follow up schedule.
- •Serious systemic or groin infection.
- •Uncorrectable coagulopathy.
- •Age < 18 years.
- •Mycotic aneurysm.
- •Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome (unless proximal implantation is into a previously placed surgical graft).
- •Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, urethane or gold.
- •Participation in another in another investigational device or drug study within 1 year of treatment.
- •Unrelated concomitant major surgical or interventional procedure(s) within 30 days of treatment date (with the exception of staged procedures planned as part of treatment)
- •Body habitus that would inhibit X-ray visualization of the aorta.
- •Acute aortic dissection
- •Patients able and willing to be treated with a commercially available device or a device being evaluated in a manufacturer-sponsored pivotal study
结局指标
主要结局
Technical Success
时间窗: Intraoperative
Successful deployment of the TAAA device or Physician-Specified TAAA Devices, or Aortic Arch device \& bridging covered stents into all targeted mesenteric \& renal, or supra-aortic arteries with stent-graft \& all branches patent by intraop angiography
Freedom from aneurysm-related mortality at 1 year
时间窗: 1 year
Survival from aneurysm-related death.
Treatment success at 12 months post-procedure
时间窗: 1 year
Composite endpoint which includes Technical Success, Procedural Success, and freedom from aneurysm-related mortality
Procedural Success
时间窗: 30 days
Technical success plus freedom from type I or III endoleak, loss of target vessel patency, death, major stroke, paralysis, new onset permanent hemodialysis, major amputation, \& bowel infarction following deployment of the branched stent-graft.
次要结局
- Freedom from reintervention(Yearly through 5 years)
- Freedom from endoleak(Yearly through 5 years)
- Freedom from loss of target vessel patency(Yearly through 5 years)
- Target artery patency(Yearly through 5 years)
- Freedom from all-cause mortality(Yearly through 5 years)
- Freedom from aneurysm rupture and conversion to open repair(Yearly through 5 years)
- Freedom from aneurysm dilatation(Yearly through 5 years)
- Freedom from serious adverse events (SAE) and major complications(Yearly through 5 years)
- Freedom from stent graft migration and branch device migration(Yearly through 5 years)
- Freedom from major stroke(Yearly through 5 years)
- Freedom from paralysis(Yearly through 5 years)
- Freedom from onset permanent hemodialysis(Yearly through 5 years)
- Freedom from bowel infarction(Yearly through 5 years)
- Freedom from amputation(Yearly through 5 years)
研究者
Darren Schneider, M.D.
Chief, Vascular Surgery and Endovascular Therapy
University of Pennsylvania
研究点 (4)
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