NCT07611968招募中不适用
Prospective Evaluation of Physician Modified Endografts for Aortic Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
The purpose of this research is to assess safety and preliminary effectiveness of the Physician-Modified Terumo Treo Abdominal Stent-Graft System.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An aneurysm with a maximum diameter of >5.5cm in males and >5.0cm in females in diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements
- •Aneurysm with a history of growth > 0.5 cm in 6 months
- •Saccular aneurysm deemed at significant risk for rupture
- •Symptomatic aneurysm
- •Extent of aorta to be treated: type II, III and IV thoracoabdominal.
- •Subject is at high-risk of morbidity and mortality with open surgical repair as defined by FEV1 of <1 liter or uncorrectable coronary disease, frailty, hostile abdomen.
- •Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit.
- •Non-aneurysmal aortic segment proximal to the aneurysm (neck) with a:
- •Minimum neck length of 15mm
- •Diameter in the range of 17-32
- •Minimum branch vessel diameter greater than 5 mm
- •Iliac artery distal fixation site
- •An inside diameter of 8mm - 13mm and a length of ≥ 10mm or
- •an inside diameter of > 13mm - 20mm and a length of ≥ 15mm
- •Age: ≥50 years old
排除标准
- •Can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis
- •Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site
- •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
- •Ruptured aneurysms
- •Prior aortic repair
- •Patient is eligible for treatment with an FDA-approved marketed device and patient can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturer-made device at another institution.
- •Known sensitivities or allergies to the materials of construction of the devices, including nitinol, polyester, PTFE, stainless steel, platinum/iridium, tantalum markers.
- •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 exceed the safe capacity of the equipment
- •Subject has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned < 30 days of endovascular repair
- •Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina)
- •Systemic or local infection that may increase the risk of endovascular graft infection
- •Baseline creatinine greater than 2.0 mg/dL
- •Thrombus or excessive calcification within the neck of the aneurysm
- •Branch stenosis >50% not amenable to endovascular preparation
研究组 & 干预措施
Abdominal aortic aneurysm repair
Experimental
干预措施: Physician-Modified Terumo Treo Abdominal Stent-Graft System (Device)
研究者
Young M. Erben
Principal Investigator
Mayo Clinic
研究点 (1)
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