RecruitingNot ApplicableNCT01874197

Branched Thoracic Endovascular Grafts for the Treatment of Thoraco-abdominal Aortic

Branched Thoracic Endovascular Grafts for the Treatment of Thoraco-abdominal Aortic Aneurysms: An Investigator-Initiated Study


Sponsor

University of Washington

Enrollment

290 participants

Start Date

Aug 1, 2012

Study Type

INTERVENTIONAL

Conditions

Summary

An investigator-initiated, prospective, consecutively enrolling, non-randomized single institution clinical evaluation of the safety and effectiveness of branched and fenestrated-branched endovascular stent grafts to preserve branch vessels when used in the treatment of patients with thoraco-abdominal aortic aneurysms. The study evaluates non-FDA-approved off the shelf and custom made branched and fenestrated-branched stent grafts manufactured by Cook Medical. The primary objectives of this study are to determine whether fenestrated-branched and branched endovascular grafts are a safe and effective method of treating patients with thoraco-abdominal aortic aneurysms.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a specially branched endovascular (inside the blood vessel) graft device used to treat complex aortic aneurysms — dangerous bulges in the large artery that runs through the chest and abdomen. These aneurysms involve blood vessels that supply vital organs like the kidneys and intestines, making standard surgical repair very risky. This minimally invasive approach aims to fix the aneurysm while preserving blood flow to those organs. You may be eligible if... - You are over 18 years old - You have a thoraco-abdominal aortic aneurysm meeting specific size or growth criteria - You are considered high risk for open surgical repair due to heart, lung, kidney, or other medical problems - You have appropriate blood vessel anatomy for the device - Your life expectancy is greater than 1 year - You have adequate arterial access for device delivery You may NOT be eligible if... - You have an active systemic infection or a mycotic (fungal) aneurysm - You have a known allergy to contrast dye that cannot be treated - You have an absolute contraindication to blood thinners - You have a known allergy to stainless steel, nickel, or gold - You have a history of connective tissue disease such as Marfan or Ehlers-Danlos syndrome - You have had a recent major surgery unrelated to the aneurysm - You have unstable chest pain or hemodynamic instability - You are currently enrolled in another investigational trial 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

DEVICEB-TEVAR device

Implantation of the Branched Thorcoabdominal aortic anerysm device


Locations(1)

University of Washington/Harborview Medical Center

Seattle, Washington, United States

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NCT01874197