Visceral Manifold and Unitary Device Study for the Repair of Thoracoabdominal Aortic Aneurysms (NCT02294435) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Visceral Manifold and Unitary Device Study for the Repair of Thoracoabdominal Aortic Aneurysms
United States250 participantsStarted 2015-02
Plain-language summary
The primary objective of the Visceral Manifold and Unitary Device Study is to assess the use of the thoracic bifurcation and the visceral manifold or the unitary device to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device. Additionally, the study will assess technical success and treatment success at each follow-up interval.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* An aneurysm with a maximum diameter of ≥ 5.5 cm or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements
* Aneurysm with a history of growth ≥ 0.5 cm in 6 months
* Saccular aneurysm deemed at significant risk for rupture
* Symptomatic aneurysm greater than or equal to 4.5 cm
* Axillary or brachial and iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit
* Proximal landing zone for the thoracic bifurcation stent graft:
•≥ 2.5 cm of nonaneurysmal aortic segment including previously placed graft material (neck) distal to the left subclavian artery (LSA)
* Diameter in the range of 26-42 mm
* Adequate distance from the celiac artery, in order to accommodate cannulation from the antegrade access point when considering the total deployed length of the thoracic bifurcation and visceral manifold
* Proximal landing zone for the unitary manifold stent graft:
* Nonaneurysmal aortic segment including previously placed graft material (neck) with a minimum seal zone length of 3 cm
* Diameter in the range of 19-32 mm
* Iliac artery or aortic distal fixation site greater than or equal to 15 mm in length and diameter in the range of 8 - 25 mm
* Age: ≥ 18 years old
* Life expectancy: \> 1 year
Exclusion Criteria:
General exclusion
* Patient is a good candidate for and elects for …
What they're measuring
1
Freedom from major adverse events (MAEs) at 30 days