Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Endovascular Branched Stent-Graft.
- Кому может быть актуально
- Состояния в реестре: Thoracoabdominal Aortic Aneurysm, Paravisceral Abdominal Aortic Aneurysm. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Обзор
This is a study to assess the safety and effectiveness of endovascular treatment of thoracoabdominal (TAAA) and paravisceral abdominal (PVAAA) aortic aneurysms. The investigational operation involves placing a stent-graft over the aortic aneurysm.
Подробное описание
A TAAA or PVAAA is an abnormal enlargement of the aorta, the main artery in the chest and abdomen. The standard operation for TAAA of PVAAA is performed through a long incision extending down the side of the chest and the front of the abdomen. In the standard operation, the weak area of the aorta is replaced with a fabric sleeve (graft). The investigational operation is done making small incisions in both groins and the right arm and placing a graft in the aorta through tubes that are inserted through the femoral and brachial arteries, than fastening it in position with metal springs(stents). The combination of a stent and a graft is known as a stent-graft. Compared with standard operation, the potential advantages of endovascular TAAA/PVAAA repair include less pain, less disturbance of intestinal function, a lower risk of pulmonary or cardiac complications and shorter hospital stay. The main disadvantage of endovascular TAAA/PVAAA is an unknown success rate.
Вмешательства
- Устройство Endovascular Branched Stent-Graft
Industry manufactured branched stent-graft for treatment of TAAA/PVAAA.
Первичные конечные точки
- Successful implantation of TAAA branched stent-graft. [Срок оценки: 1 month]
Вторичные конечные точки (1)
- Long term success of TAAA branched stent-graft treatment. [Срок оценки: 5 years]
Критерии участия
Критерии включения
- Aortic aneurysms:
- greater than or equal to 6 cm in diameter in men,
- greater than or equal to 5.5 cm in diameter in women,
- and/or larger than 5 cm in diameter and enlarging at a rate of more than 5 mm/year,
- and/or iliac aneurysms larger than 4 cm in diameter.
- Anticipated mortality comparable to published rates with conventional surgical treatment.
- Life expectancy more than 2 years.
- Ability to give informed consent.
- Willingness to comply with follow-up schedule.
- Suitable arterial anatomy for endovascular repair.
Критерии исключения
- Free rupture of the aneurysm.
- Pregnancy.
- Known allergy to Nitinol, stainless steel, or polyester.
- Unwillingness or inability to comply with the follow up schedule.
- Serious systemic or groin infection.
- Uncorrectable coagulopathy.
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 · 2 центра
- Division of Vascular Surgery, SFVAMC — San Francisco
- Division of Vascular Surgery, UCSF — San Francisco
Публикации
- Crawford ES, DeNatale RW. Thoracoabdominal aortic aneurysm: observations regarding the natural course of the disease. J Vasc Surg. 1986 Apr;3(4):578-82. doi: 10.1067/mva.1986.avs0030578. PMID 3959256
- Svensson LG, Crawford ES, Hess KR, Coselli JS, Safi HJ. Experience with 1509 patients undergoing thoracoabdominal aortic operations. J Vasc Surg. 1993 Feb;17(2):357-68; discussion 368-70. PMID 8433431
- Martin GH, O'Hara PJ, Hertzer NR, Mascha EJ, Krajewski LP, Beven EG, Clair DG, Ouriel K. Surgical repair of aneurysms involving the suprarenal, visceral, and lower thoracic aortic segments: early results and late outcome. J Vasc Surg. 2000 May;31(5):851-62. doi: 10.1067/mva.2000.106481. PMID 10805874
- Cambria RP, Davison JK, Carter C, Brewster DC, Chang Y, Clark KA, Atamian S. Epidural cooling for spinal cord protection during thoracoabdominal aneurysm repair: A five-year experience. J Vasc Surg. 2000 Jun;31(6):1093-102. doi: 10.1067/mva.2000.106492. PMID 10842145
- Walker SR, Yusuf SW, Wenham PW, Hopkinson BR. Renal complications following endovascular repair of abdominal aortic aneurysms. J Endovasc Surg. 1998 Nov;5(4):318-22. doi: 10.1583/1074-6218(1998)0052.0.CO;2. PMID 9867320
- Thompson JP, Boyle JR, Thompson MM, Strupish J, Bell PR, Smith G. Cardiovascular and catecholamine responses during endovascular and conventional abdominal aortic aneurysm repair. Eur J Vasc Endovasc Surg. 1999 Apr;17(4):326-33. doi: 10.1053/ejvs.1998.0760. PMID 10204055
- Zarins CK, White RA, Schwarten D, Kinney E, Diethrich EB, Hodgson KJ, Fogarty TJ. AneuRx stent graft versus open surgical repair of abdominal aortic aneurysms: multicenter prospective clinical trial. J Vasc Surg. 1999 Feb;29(2):292-305; discussion 306-8. doi: 10.1016/s0741-5214(99)70382-4. PMID 9950987
- May J, White GH, Yu W, Ly CN, Waugh R, Stephen MS, Arulchelvam M, Harris JP. Concurrent comparison of endoluminal versus open repair in the treatment of abdominal aortic aneurysms: analysis of 303 patients by life table method. J Vasc Surg. 1998 Feb;27(2):213-20; discussion 220-1. doi: 10.1016/s0741-5214(98)70352-0. PMID 9510276
Идентификаторы
NCT: NCT00483249 · 10-02810