Thoracic aneurysm
Conditions
Interventions
Endovascular implant of a stent graft. Each stent graft is advanced from a
transfemoral or transiliac approach over a 0.035* guidewire and positioned
under fluoroscopic control. If necessary, an art
Sponsors
Vascutek Limited
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with aneurysms or penetrating ulcers of the descending thoracic aorta;Main Inclusion criteria: 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
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, 35 mm. 3. Subject's distal neck diameter, 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety endpoint will be the proportion of subjects who do not sustain any major adverse events (MAEs) *30 days post-procedure. A MAE is defined as the occurrence of any of the following: * Respiratory complications: atelectasis/pneumonia, pulmonary embolism, pulmonary oedema, respiratory failure. * Renal complications: renal failure, renal insufficiency. * Cardiac complications: MI, unstable angina, new arrhythmia, exacerbation of congestive heart failure. * Neurological: New CVA/embolic events, paraplegia/paraparesis * Aneurysm rupture * Gastrointestinal: bowel ischemia * Major bleeding complications (procedural or post procedural), coagulopathy * Vascular complications * Death due to device or procedure related complications, internal bleeding, vascular repair, transfusion reaction or conversion to open surgical TAA repair. The primary effectiveness endpoint will be successful aneurysm treatment, defined as a composite endpoint of subjects who have successful delivery and deployment of the ThoraflexTM at the initial procedure and are free from the following at * 365 days post-procedure: * Aneurysm growth >5 mm from baseline measurement (Pre-Discharge CT Scan) * Post-operative interventions to correct type I or III endoleaks * Conversion to open surgical repair * Failed patency of the stent graft * Migration requiring secondary intervention * Significant failure of stent graft integrity * Aneurysm rupture | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical Success Technical success is defined as the introduction and deployment of ThoraflexTM (with any ancillary endovascular components deemed necessary such as extensions or stents) in the absence of mortality, conversion to surgical repair, failed patency or evidence of a type I or III endoleak in the first 24 hour post- operative period (defined on procedural angiography). Components of technical success to be evaluated as secondary effectiveness outcomes include: * Incidence of type I or III endoleak. The incidence of subjects with freedom from type I and III endoleaks will be the focus of assessments, however type II and IV endoleaks will be recorded and evaluated for rates of occurrence. * Stent graft patency, defined as the presence of blood flow within the graft as determined through imaging analysis. * Conversion to surgical repair. These outcomes will also be evaluated throughout the study, however, only events occurring *24 hours post-procedure will be assessed for technical success. For example, a type I endoleak discovered at 180 days post-procedure will not be considered a technical failure, but will be evaluated as a component measurement. Mortality will be assessed separately as a safety outcome. Changes in Aneurysm Size Aneurysm size will be evaluated pre-procedure and at discharge, 1, 6 and 12 months post-procedure. It is anticipated that in the initial post-implant period the aneurysm sac may increase slightly in diameter as has been reported elsewhere for this type of procedure. Therefore, although aneurysm size will be evaluated at 1 month, this will only be evaluated as a component measurement. A significant size change, compared with pre-procedure, will be considered to be a decrease or increase in diameter >5 mm as measured along the major axis diameter. Assessment of Aneurysm Rupture Aneurysm rupture will be defined as the expansion of the blood vessel to the extent of leakage of blood into the body cavity | — |
Countries
Netherlands
Outcome results
None listed