RecruitingNot ApplicableNCT01524211

Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms


Sponsor

Baptist Health South Florida

Enrollment

235 participants

Start Date

Jan 25, 2012

Study Type

INTERVENTIONAL

Conditions

Summary

Zenith t-Branch Study Cohort: The purpose of this study is to collect information on the Cook Zenith t-Branch endovascular stent-graft system and the Terumo Arch Branch for the treatment of aortic aneurysms. Terumo Arch Branch Study Cohort: The purpose of this additional study arm to the current IDE clinical trial is to collect a priori information on the Terumo Arch Branch Endograft for the treatment of proximal thoracic aortic pathologies that cannot be treated with conventional thoracic endografts.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates branch endografts — specialized medical devices used in minimally invasive surgery to repair complex aortic aneurysms (dangerous bulges in the large blood vessel in the chest or abdomen). Two device types are studied: the Zenith t-Branch and the Terumo Arch Branch endograft. You may be eligible if: - You are 18 years of age or older and not pregnant - You have a thoracoabdominal, suprarenal, or juxtarenal aortic aneurysm of 55 mm or larger in diameter (or 50 mm in females), rapidly growing, or symptomatic - OR you have a penetrating aortic ulcer of 20 mm or deeper, or a chronic type B aortic dissection of 50 mm or greater - For the arch branch device: your condition is high-risk for standard open surgical repair You may NOT be eligible if: - You have a life expectancy of less than 12 months - You refuse blood products - You are pregnant or breastfeeding - You have an active or uncontrolled infection, untreatable malignancy, or severe contrast allergy - The anatomy of your aorta is not suitable for the device Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEZenith® t-Branch

The t-Branch Endovascular Graft (Zenith® t-Branch) is a tubular graft with four branches and a covered stent at the proximal end that contains barbs for additional fixation of the device. The purpose of the branches is to allow uninterrupted blood flow to visceral vessels of the aorta. The graft is designed to be connected with celiac, superior mesenteric and two renal arteries via self-expanding covered bridging stents. Although the standard Zenith t-Branch has four branches, it is anticipated that a small number of custom-made three branch devices will be included in this study for those patients in whom one of the visceral vessels is chronically thrombosed.

DEVICETerumo Arch Branch

The Arch Branch endograft is a custom-made endograft based on the Relay thoracic stent graft platform. The device is intended to land proximally in the ascending aorta just distal to the sinotubular junction, and distally either in the native thoracic aorta for focal arch pathologies, or more extensive pathologies either extended with another commercially available thoracic endograft or mated to a pre-existing thoracic endograft, which would serve as a distal landing zone. It is constructed of polyester graft material (same as those used for the Terumo Relay Plus or Pro) sewn to self-expanding nitinol stents with suture. The graft is fully stented to provide stability and the expansile force necessary to open the lumen of the graft during deployment. Additionally, the stents provide the necessary attachment and seal of the graft to the aortic wall.


Locations(1)

Baptist Health South Florida|Boca Raton Regional Hospital (BRRH)

Boca Raton, Florida, United States

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NCT01524211


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