Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Respiratory Failure
研究概览
简要总结
The purpose of this study is to assess the effects of a physician-modified endovascular graft (PMEG) for juxtarenal aortic aneurysms by collecting data on its performance. Participants in the study will undergo surgery to repair their juxtarenal aortic aneurysm using the PMEG device. After the surgery, participants will attend several follow-up visits to monitor their recovery and the device's effectiveness. These follow-up visits will take place at hospital discharge, then at 1 month, 6 months, 12 months, and once a year for up to 5 years after surgery.
详细描述
A juxtarenal aortic aneurysm is an aneurysm that occurs near the renal arteries, which bring blood to the kidneys. This research study will evaluate if the physician-modified endovascular graft (PMEG) is safe and effective in the treatment of juxtarenal aortic aneurysms. The PMEG device is an investigational device, which means it has not been approved by the FDA. The device is designed to create a pathway through the aneurysm for blood flow to the arteries, reducing the blood pressure that the aneurysm experiences. There are several types of endovascular devices depending on how big the aneurysm is, where the aneurysm is located in relation to the kidney, or other physical measurements of the blood vessels. The upper portion of the device, or stent graft, will include between one and four holes (fenestrations). The holes allow the device to be located above the renal arteries (the blood vessels that supply blood to the kidneys) without blocking the blood flow to them. Smaller grafts are then placed in the blood vessels to the kidneys, the intestines, and liver to be connected to the main aortic graft, allowing blood to flow to the organs.
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
- •Patient is ≥ 18 years of age
- •Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study)
- •Patient or Legally Authorized Representative has signed an Institutional Review Board (IRB) approved Informed Consent Form
- •Patient has a juxtarenal abdominal aortic aneurysm that meets at least one of the following:
- •An aneurysm with a maximum diameter of ≥ 5.5 cm for male (≥ 5.0 cm for female) or 2 times the normal 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
- •Ruptured aneurysm
- •Patient has patent iliac or femoral arteries, with or without the use of conduit, that will allow endovascular access with the physician modified endovascular graft.
- •Patient has a suitable non-aneurysmal proximal aortic neck of ≥ 2 mm inferior to the most distal renal artery ostium.
- •Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥ 15mm. The resultant repair should preserve patency in at least one hypogastric artery.
- •Patient has a suitable non-aneurysmal proximal aortic neck diameter between 20 and 32 mm, averaged across the diameters at the Celiac, SMA, at the lowest patent renal artery and at the midpoint of the renal arteries.
- •Patient has suitable non-aneurysmal distal common iliac diameters between 8 and 20 mm.
- •Patient has juxtarenal aortic neck angulation ≤ 60°
- •Target branch vessel diameter ≥ 5 mm.
- •Patient must be willing to comply with all required follow-up exams.
排除标准
- •Patient has a mycotic aneurysm or has an active systemic or local infection that may increase the risk of endovascular infection
- •Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)
- •Patient has a major surgical or interventional procedure, not related to the endovascular repair, planned within +/- 30 days of the AAA repair.
- •Patient has history of an aortopathic connective tissue disease (e.g. Marfan's or Ehler's-Danlos syndrome).
- •Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.
- •Patient has known allergy or intolerance to stainless steel, nitinol or gold (gold-coated tungsten).
- •Patient has a body habitus that would inhibit X-ray visualization of the aorta
- •Patient has a limited life expectancy of less than 1 year
- •Patient is currently participating in another investigational device or drug clinical trial
- •Patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.
- •Thrombus or excessive calcification within the neck of the aneurysm
- •Branch vessel stenosis ≥ 80%
- •Patient treatable on label with FDA approved EVAR or FEVAR device and can wait for device availability.
- •Subject is willing and eligible to enroll in a manufacturer-sponsored study at the investigational site, or the subject is willing and eligible to participate in a study with a manufacturer-made device at another institution.
研究组 & 干预措施
Physician Modified Endograft
Surgical procedure to repair the juxtarenal abdominal aortic aneurysm, during which the physician-modified endovascular graft (PMEG) device will be used.
干预措施: Endovascular Aneurysm Repair with Physician Modified Endograft (Device)
结局指标
主要结局
Respiratory Failure
时间窗: 30 days post index procedure
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure, including respiratory failure.
Paraplegia
时间窗: 30 days post index procedure
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure, including paraplegia.
Bowel Ischemia
时间窗: 30 days post procedure
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure, including bowel ischemia.
Procedural Blood Loss (>1000 cc)
时间窗: 30 days post procedure
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure, including procedural blood loss (\>1000 cc).
All Cause Mortality
时间窗: 30 days post index procedure
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure, including all-cause mortality.
Myocardial Infarction
时间窗: 30 days post index procedure
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure, including myocardial infarction.
Stroke
时间窗: 30 days post index procedure
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure, including stroke.
Renal Failure
时间窗: 30 days post index procedure
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure, including renal failure.
Respiratory Failure
时间窗: 30 days post index procedure
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure, including respiratory failure.
Paraplegia
时间窗: 30 days post index procedure
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure, including paraplegia.
Bowel Ischemia
时间窗: 30 days post procedure
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure, including bowel ischemia.
Procedural Blood Loss (>1000 cc)
时间窗: 30 days post procedure
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure, including procedural blood loss (\>1000 cc).
Renal Failure
时间窗: 30 days post index procedure
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure, including renal failure.
Treatment Success
时间窗: 12 months post index procedure
The primary effectiveness endpoint is the proportion of subjects that achieve Treatment Success. Treatment Success is a composite endpoint assessed at 12 months that requires the following criteria to be met: Technical Success (at the index procedure) is defined by the following: 1. The physician was able to insert the delivery catheter and deliver the physician modified endovascular graft to the treatment site and preserve blood flow into the vessels intended to have blood flow preserved. 2. Freedom from Type I \& III endoleaks at 12 months 3. Freedom from stent graft migration at 12 months 4. Freedom from aortic aneurysm enlargement at 12 months 5. Freedom from aortic aneurysm rupture and conversion to open repair through 12 months
All Cause Mortality
时间窗: 30 days post index procedure
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure, including all-cause mortality.
Myocardial Infarction
时间窗: 30 days post index procedure
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure, including myocardial infarction.
Stroke
时间窗: 30 days post index procedure
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure, including stroke.
Treatment Success
时间窗: 12 months post index procedure
The primary effectiveness endpoint is the proportion of subjects that achieve Treatment Success. Treatment Success is a composite endpoint assessed at 12 months that requires the following criteria to be met: Technical Success (at the index procedure) is defined by the following: 1. The physician was able to insert the delivery catheter and deliver the physician modified endovascular graft to the treatment site and preserve blood flow into the vessels intended to have blood flow preserved. 2. Freedom from Type I \& III endoleaks at 12 months 3. Freedom from stent graft migration at 12 months 4. Freedom from aortic aneurysm enlargement at 12 months 5. Freedom from aortic aneurysm rupture and conversion to open repair through 12 months
Respiratory Failure
时间窗: 30 days post index procedure
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure, including respiratory failure.
Procedural Blood Loss (>1000 cc)
时间窗: 30 days post procedure
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure, including procedural blood loss (\>1000 cc).
次要结局
- Device integrity failure(30 days, 6 months, and annually through 5 years post index procedure.)
- Conversion to open repair(30 days, 6 months, and annually through 5 years post index procedure.)
- All endoleaks(30 days, 6 months, and annually through 5 years post index procedure.)
- Secondary Intervention(30 days, 6 months, and annually through 5 years post index procedure.)
- Mortality(30 days, 6 months, and annually through 5 years post index procedure)
- Aneurysm related mortality(30 days, 6 months, and annually through 5 years post index procedure)
- Aneurysm Rupture(30 days, 6 months, and annually through 5 years post index procedure.)
- Major Adverse Events (MAE)(30 days, 6 months, and annually through 5 years post index procedure)
- Renal failure with or without permanent dialysis(30 days, 6 months, and annually through 5 years post index procedure.)
- Graft Infection(30 days, 6 months, and annually through 5 years post index procedure.)
- Technical Success(30 days, 6 months, and annually through 5 years post index procedure)
- Stent graft migration > 10 mm(30 days, 6 months, and annually through 5 years post index procedure.)
- All endoleaks(30 days, 6 months, and annually through 5 years post index procedure.)
- AAA enlargement(30 days, 6 months, and annually through 5 years post index procedure.)
- Patency related events(30 days, 6 months, and annually through 5 years post index procedure.)
- Device integrity failure(30 days, 6 months, and annually through 5 years post index procedure.)
- Conversion to open repair(30 days, 6 months, and annually through 5 years post index procedure.)
- Secondary Intervention(30 days, 6 months, and annually through 5 years post index procedure.)
- Patency related events(30 days, 6 months, and annually through 5 years post index procedure.)
- Mortality(30 days, 6 months, and annually through 5 years post index procedure)
- Aneurysm related mortality(30 days, 6 months, and annually through 5 years post index procedure)
- Aneurysm Rupture(30 days, 6 months, and annually through 5 years post index procedure.)
- Major Adverse Events (MAE)(30 days, 6 months, and annually through 5 years post index procedure)
- Renal failure with or without permanent dialysis(30 days, 6 months, and annually through 5 years post index procedure.)
- Graft Infection(30 days, 6 months, and annually through 5 years post index procedure.)
- Technical Success(30 days, 6 months, and annually through 5 years post index procedure)
- Stent graft migration > 10 mm(30 days, 6 months, and annually through 5 years post index procedure.)
- AAA enlargement(30 days, 6 months, and annually through 5 years post index procedure.)
- Device integrity failure(30 days, 6 months, and annually through 5 years post index procedure.)
- Conversion to open repair(30 days, 6 months, and annually through 5 years post index procedure.)
研究者
Cali Johnson
Assistant Professor
University of Utah