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
University of Washington
290 participants
Aug 1, 2012
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
Inclusion Criteria20
- 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 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 a life expectancy of greater than 1 year.
- 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:
- with a length of 25 mm of proximal seal in non-aneurysmal aorta, with or without coverage of the left subclavian artery,
- with an outer wall diameter of no less than 20 mm and no greater 38mm, 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 38 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.
Exclusion Criteria14
- Patients that meet ANY of the following are not eligible for enrollment into the study:
- Patient has an active systemic infection
- Patient has a mycotic aneurysm.
- Patient has a known hypersensitivity to contrast media that is not amenable to pre-treatment.
- Patient has an absolute contra-indication to anticoagulation
- Patient has a known allergy or intolerance to stainless steel, nickel, or gold
- Patient has a body habitus that would inhibit adequate X-ray visualization of the aorta
- Patient has a dominant artery to the spinal cord arising from an area of stent graft coverage that is not amenable to preservation using an endovascular branch
- Patient is currently participating in another investigational device or drug clinical trial
- Patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.
- Patient has a freely ruptured TAAA with hemodynamic instability
- Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)
- Patient has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned within 30 days of the TAAA repair. Adjunctive procedures for treatment of the TAAA (i.e. carotid-subclavian bypass or iliac conduit) are acceptable.
- Patient has a history of connective tissue disease (e.g. Marfan or Ehlers Danlos syndromes)
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Interventions
Implantation of the Branched Thorcoabdominal aortic anerysm device
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT01874197