Valiant Evo International Clinical Trial

Completed

Conditions: Thoracic aortic aneurysm/ TAA / enlargement of the aorta in the chest
10002363

Registration Number: NL-OMON45800

Lead Sponsor: Medtronic B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 4

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 <50 mm and has grown >= 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 <= 42 mm
b. Proximal non-aneurysmal aortic neck length must be >= 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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Composite safety and effectiveness endpoint that is based on the proportion of<br /><br>subjects who experienced:<br /><br>(a) Access and/or deployment failures; and/or<br /><br>(b) Major device effect (MDE) within 30 days post index procedure<br /><br>MDEs include the occurrence of any of the following and are defined in Appendix<br /><br>L.2.1:<br /><br>• Device-related secondary procedures<br /><br>• Device-related mortality<br /><br>• Conversion to open surgery<br /><br>• Thoracic aortic aneurysm rupture<br /><br>An independent Clinical Events Committee (CEC) will be established to<br /><br>adjudicate MDEs.</p><br>

Secondary Outcome Measures