Thoracic aortic aneurysm/ TAA / enlargement of the aorta in the chest
Conditions
Interventions
Since the patient would have been treated with an thoracic stent graft anyway,
the intervention in this study is the use of the
Valiant Evo thoracic stentgraft, a third generation thoracic stent.
Sponsors
Medtronic B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject is >=18 years old 2. Subject understands and voluntarily has signed and dated the Patient Informed Consent approved by the Sponsor and by the Ethics Committee for this study 3. Subject presents a DTAA which is localized below the ostium of left subclavian artery (LSA) and above the ostium of celiac trunk 4. Subject has a DTAA that is one of the following: a. A fusiform aneurysm with a maximum diameter that: · is >= 50 mm and/or: · is >= 2 times the diameter of the non-aneurysmal thoracic aorta and/or: · is = 5 mm within previous 12 months b. A saccular aneurysm or a penetrating atherosclerotic ulcer 5. Subject*s anatomy must meet all of the following anatomical criteria as demonstrated on contrast-enhanced CT and/or on contrast-enhanced MRI obtained within four (4) months prior to implant procedure: a. Proximal and distal non-aneurysmal aortic neck diameter measurements must be >= 16 mm and = 20 mm (for FreeFlo configuration) and >= 25 mm (for Closed Web configuration) c. Distal non-aneurysmal aortic neck length must be >= 20 mm Subject has adequate arterial access site or can tolerate a conduit that allows endovascular access to the aneurysmal site with the delivery system of the
Exclusion criteria
Exclusion criteria: 1. Subject has a life expectancy of less than 1 year 2. Subject is participating in another investigational drug or device study which would interfere with the endpoints and follow-ups of this study 3. Subject is pregnant 4. Subject requires planned placement of the covered proximal end of the stent graft to occur in zones 0 or 1 5. Subject has a thoracic aneurysm with a contained rupture or localized at the anastomosis of a previous graft (pseudo-/false aneurysm) 6. Subject has a mycotic aneurysm 7. Subject has a dissection (type A or B) or an intramural hematoma or an aortic rupture in addition to the thoracic aneurysm 8. Subject requires emergent aneurysm treatment, e.g., trauma or rupture 9. Subject has received a previous stent or stent graft or previous surgical repair in the ascending and/or descending thoracic aorta, and/or in the aortic arch 10. Subject requires surgical or endovascular treatment of an infra-renal aneurysm at the time of implant 11. Subject has had previous surgical or endovascular treatment of an infra-renal aortic aneurysm 12. Treatment with the Valiant Evo Thoracic Stent Graft would require intentional revascularization of the brachio-cephalic artery, the left common carotid artery or the celiac trunk 13. Subject has had or plans to have a major surgical or interventional procedure within 30 days before or 30 days after the planned implantation of the Valiant Evo Thoracic Stent Graft. This does not include planned procedures that are needed for the safe and effective placement of the stent graft (i.e., carotid/subclavian transposition, carotid/subclavian bypass procedure) 14. Subject has a significant and/or circumferential aortic mural thrombus at either the proximal or distal attachment sites that could compromise fixation and seal of the implanted stent graft 15. Subject has a connective tissue disease (e.g., Marfan*s syndrome, aortic medial degeneration) 16. Subject has a bleeding diathesis or coagulopathy, or refuses blood transfusion. 17. Subject has had a MI within 3 months of the procedure 18. Subject has had a CVA within 3 months of the procedure 19. Subject has a known allergy or intolerance to the device materials 20. Subject has a known allergy to anesthetic drugs 21. Subject has a known hypersensitivity or contraindication to anticoagulants, or contrast media, which is not amenable to pretreatment 22. Subject has active or systemic infection at the time of the index procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite safety and effectiveness endpoint that is based on the proportion of subjects who experienced: (a) Access and/or deployment failures; and/or (b) Major device effect (MDE) within 30 days post index procedure MDEs include the occurrence of any of the following and are defined in Appendix L.2.1: • Device-related secondary procedures • Device-related mortality • Conversion to open surgery • Thoracic aortic aneurysm rupture An independent Clinical Events Committee (CEC) will be established to adjudicate MDEs. | — |
Secondary
| Measure | Time frame |
|---|---|
| 30-day Secondary Endpoints: The following secondary endpoints will be evaluated within 30 days post treatment: · Peri-operative mortality · All adverse events (AE) within 30 days including: • Major Adverse Event(s) (MAE) • Serious Adverse Event(s) (SAE) · Secondary procedures · Loss of stent graft patency at 30 day visit based on imaging findings · Endoleaks at 30 day visit based on imaging findings Major adverse events include the occurrence of any of the following: · Respiratory complications: atelectasis, pneumonia, pulmonary embolism, pulmonary edema, respiratory failure · Renal complications: renal failure, renal insufficiency · Cardiac complications: Myocardial infarction (MI), unstable angina, new arrhythmia, exacerbation of congestive heart failure (CHF) · Neurological complications: new cerebrovascular accident (CVA), cerebrovascular embolic events, paraplegia, paraparesis · Gastrointestinal complications: bowel ischemia · Major bleeding complication (procedural or post-procedural), coagulopathy · Vascular complications: aortic rupture, hematoma at access site, pseudo or false aneurysm, arteriovenous (AV) fistula, retroperitoneal bleed, limb ischemia, thrombosis 12-month Secondary Endpoints: The following secondary endpoints will be evaluated: · All-cause mortality within 365 days · Aneurysm-Related Mortality within 365 days · MDEs within 365 days · All AEs within 365 days including: • MAEs • SAEs · Secondary procedures within 365 days · Loss of stent graft patency within 12 months based on imaging findings · Endoleaks at 12 months based on imaging findings · Stent graft migration at 12 months as compared to 1-month imaging · Aneurysm expansion > 5mm at 12 months based on imaging findings relative to the 1-month visit | — |
Countries
Netherlands
Outcome results
None listed