Active — Not RecruitingNot Applicable

Visceral Manifold Study for the Repair of TAAA

United States15 participantsStarted 2017-12-19

Plain-language summary

The outcomes from prior clinical evaluation of the study device, including successfully treating 99% (84/85) of the intended target vessels and 96% (27/28) limb patency observed at one year, demonstrate the potential benefits of the device. When contrasted with open repair's significant complication rates and branch fenestrated device's significant anatomic and logistic limitations, the potential risk of the proposed novel graft does not outweigh the potential benefit of widened anatomic availability and improved patency rates. Given the potential benefits, the investigators feel that it is justified to expose the target patient population to the potential risk. The non-clinical testing performed by Medtronic and the clinical results reported by Sanford Health show adequate safety of the device to support an early feasibility study. The investigators would like to perform an early feasibility study under a defined and controlled protocol to collect prospective preliminary safety and device functionality data. The investigators believe an early feasibility study is most appropriate for this novel approach. The limited sample size allows adequate patient data to be collected under a controlled protocol without exposing a large patient population to the risk associated with a novel device design.

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.

Primary Study Arm Inclusion Criteria: * A patient may be entered into the study if the patient has at least one of the following: * 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 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 that has: * ≥ 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 * Minimum branch vessel diameter greater than 5 mm * Iliac artery or aortic distal fixation site, including both native tissue and previously placed graft, 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 fo…

What they're measuring

Proportion of subjects free from major adverse events

Timeframe: 30 days

Proportion of subjects with treatment success

Timeframe: at 1 year

Trial details

NCT IDNCT03075748

SponsorUniversity of South Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-01