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

Recruiting now · Not applicable

Conditions studied: Thoracoabdominal Aortic Aneurysm, Without Rupture

In brief

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.

Key facts

Study ID

NCT01874197

Run by

University of Washington

People needed

290

Starts

2012-08-01

Expected to finish

2028-08-01

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients must meet all of the following inclusion criteria to be eligible for enrollment into this study:
• Patient is > 18 years of age
• Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study.
• Patient or Legally Authorized Representative has signed an Institutional Review Board (IRB) approved Informed Consent Form
• Patient is considered by the treating physician and a second attending physician experienced in the care of patients with aneurysmal disease to be at high risk of open surgical repair due to one or more major medical co-morbidities (i.e. CAD, CHF, COPD, CRI, advanced age, generalized deconditioning, or other.) with ASA of 3 or more.
• The patient has reasonable expectation of surviving the B-TEVAR procedure and has a life expectancy of greater than 1 year as determined by the PI and a second attending physician experienced in the care of patients with aneurysmal disease.
• The patient has a thoraco-abdominal aortic aneurysm where necessary visceral branch vessels (i.e. the celiac, superior mesenteric, inferior mesenteric, renal and/or dominant spinal arteries) arise from the aneurysm or seal zones necessary for on-label thoracic endovascular repair
• Patient has a thoraco-abdominal aortic aneurysm that meets at least one of the following:
• aneurysm > 5.5 cm in diameter
• aneurysm has increased in size by 0.5 cm in last 6 months
• aneurysm is believed to be causing symptoms
• Patient has sufficient arterial access (femoral and/or iliac) that will allow delivery of the endovascular device with or without the use of a surgical conduit.
• Patient has suitable proximal (aorta) and distal (aorta or iliac) arteries to allow for adequate fixation and seal:
• A. Non-aneurysmal proximal aortic seal zone:
• Standard BTEVAR cohort will require a length of 25 mm of proximal seal in non-aneurysmal aorta, with or without coverage of the left subclavian artery.
• The BTEVAR-CTD cohort will require a length of 30 mm of proximal seal with an outer wall diameter of no less than 15 mm and no greater than 42 mm, and
• B. Non-aneurysmal distal aortic or iliac landing zone:
• With a length of at least 15 mm,
• Aortic seal zone no less than 15 mm and no greater than 42 mm or
• Iliac seal zone with an outer wall diameter of no less than 8 mm and no greater than 23 mm.
• The patient has no more than 5 necessary visceral arteries that require flow preservation.
• All target visceral artery seal zones are > 4 mm in diameter. 12. Patient must be willing to comply with all required follow-up exams.
• 1.2 Exclusion Criteria
• Patients that meet ANY of the following are not eligible for enrollment into the study:
• Patient has an active systemic infection

Where it is running

• University of Washington/Harborview Medical Center — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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