Evaluation of the Vascutek Ltd. Thoracic Endovascular Stent Graft System (Thoraflex) in the Treatment of Aneurysm or Penetrating Ulcer of the Descending Thoracic Aorta - Vascutek Thoraflex Study

Vascutek Limited0 个研究点目标入组 22 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•Patients with aneurysms or penetrating ulcers of the descending thoracic aorta;Main
•1.Subject ages > 18 years
•2.Subject has a life expectancy of at least 12 months
•3.The Subject must meet at least one of the following:
•- Descending thoracic fusiform aneurysm, 50mm in diameter or greater.
•- Descending thoracic aneurysm that is 4cm or more in diameter that has increased in size by 0.5cm in last 6 months
•- Descending thoracic aneurysm with a maximum diameter that exceeds two times the diameter of the non-aneurysmal, adjacent aorta
•- Saccular aneurysm in the descending thoracic aorta or Penetrating Atherosclerotic Ulcers (PAUs)
•4. The diagnosis is confirmed as thoracic aortic aneurysm or PAU by contrast enhanced CT obtained within the three months prior to implant.
•(all 9 inclusion criteria can be found in the protocol section 5.1)

•Main exclusion cirteria:
•1. Subject has any of the following conditions in his/her descending thoracic aorta:
•- Dissections - acute or chronic, in ascending or descending aorta
•- Acute Transection or Acute Traumatic Injury
•- Pseudoaneurysm (false aneurysm)
•- Symptomatic Aneurysm, including ruptured lesions
•2. Subject's proximal neck diameter, < 22 or > 35 mm.
•3. Subject's distal neck diameter, < 22 or > 35 mm.
•4. Subject has prohabitive calcification(>50% circumferential calcification), occulsive disease or tortuosity of intended fixation sites.
•(All 25 exclusion criteria can be found in the protocol section 5.2)

发起方

Vascutek Limited