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

Completed

• Conditions: Thoracic aneurysm; 10002363

• Registration Number: NL-OMON36276
• Lead Sponsor: Vascutek Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 22

Inclusion Criteria

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)

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified