Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms

Официальное название

Baystate Health Physician Sponsored - Investigational Device Exception: Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms

Обзор

Patients who are found to have an aneurysm (bulge) in the abdominal aorta, which is the blood vessel in your abdomen (belly) that supplies blood to most of your lower body, including major organs and your legs. As an aneurysm expands, the walls of the aorta become weak and may rupture (break open), causing a major loss of blood with a high risk of serious problems and death. To avoid this risk, doctors repair aneurysms by either open surgery (incision) or endovascular surgery (covered stents to channel the blood flow). Juxtarenal aneurysms (those that come close to the kidney arteries) present a unique challenge as they are more dangerous to repair by open therapy and do not fit the standard approved endovascular devices. The purpose of this study is to assess the effects of the physician-modified endovascular graft (PMEG) by collecting information about the performance of this investigational medical device. The main graft looks like a pair of pants with very short legs. The top of the pants is placed in the aorta. Then, two smaller grafts go from the main graft and to your iliac arteries (the main arteries supplying blood to your abdomen and legs) to form the legs of the pair of pants. Each graft is packed into a small catheter (a long, flexible plastic tube) that is placed into your aorta through the femoral artery in your groin (top of your leg). The grafts are then placed in the correct position in your aorta by releasing them from the catheters. These grafts are investigational because the research physician has changed them to match patient anatomy (body make up) while protecting blood flow to important vessels. Once the grafts are attached inside the aorta, they will support the area of the aorta that is weakened and bulging. Modifications of the graft will include between one and four holes (fenestrations) near the top of the graft. The holes allow the graft to be located above the renal arteries (the blood vessels that supply blood to your kidneys) without blocking the blood flow to them. One or more of the arteries will also be treated with a stent (metal wire tube) to help keep the arteries open and to keep the arteries connected to the holes that are made for the graft. The device is custom modified for patient specific anatomy. The information collected from this study will be used to show how well patients do when treated with the modified graft, both immediately after surgery and over a long period of time. After the procedure, labs, CT imaging with contrast, XRays and ultrasounds will be done to check the graft at intervals 1 month, 6 months, 12 months and yearly for 5 years. These are standard surveillance studies performed on any endovascular aneurysm repair.

Вмешательства

• Устройство Physician Modified Endografting
  This is the only intervention in the study

Первичные конечные точки

• Technical success [Срок оценки: Periprocedural]
• Freedom from Type I and III Endoleaks at 12 months [Срок оценки: 12 months post-procedure]
• Freedom from stent graft migration at 12 months [Срок оценки: 12 months]
• Freedom from aortic aneurysm enlargement at 12 months [Срок оценки: 12 months]
• Freedom from aortic aneurysm rupture and conversion to open repair through 12 months [Срок оценки: 12 months]

Вторичные конечные точки (6)

• Mortality [Срок оценки: 30 days, 6 months, 12 months, and annually through 5 years]
• Aneurysm related mortality [Срок оценки: 30 days, 6 months, 12 months, and annually through 5 years]
• Aneurysm Rupture [Срок оценки: 30 days, 6 months, 12 months, and annually through 5 years]
• Major Adverse Events [Срок оценки: 30 days, 6 months, 12 months, and annually through 5 years]
• Renal failure with or without permanent dialysis [Срок оценки: 30 days, 6 months, 12 months, and annually through 5 years]
• Graft Infection [Срок оценки: 30 days, 6 months, 12 months, and annually through 5 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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, nitiol, or gold (gold-plated 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 %
• Patients 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Baystate Medical Center — Springfield

Идентификаторы

NCT: NCT07019454 · 2303212-3 · G240287

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗