NCT00583817
Endovascular Treatment of Thoracic Aortic Disease
Enrolling by Invitation
NAAges 18+InterventionalTreatmentMatthew EagletonInvestigator-initiated
~170 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:Endovascular stent-graft implantation
At a glance
Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
All-cause mortality
Measured over 5 years
+2 more outcomes measured
Conditions
Where it's being run
2 sites across 1 statesMassachusetts2
Study leadership
- Matthew J Eagleton, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Life expectancy greater than 2 years
Suitable arterial anatomy
Absence of systemic disease or allergy that precludes an endovascular repair
Capable of giving informed consent and willingness to comply with follow up schedule
Patient is considered high or prohibitive risk for open surgical repair of the ascending aneurysm or dissection
Have ONE of the following
Must meet ALL of the following:
Proximal fixation may occur in either native aorta or surgical graft
In the setting of the aortic dissection, the proximal fixation must be proximal to the entry tear.
In the setting of aortic dissection, true lumen size must be large enough to allow deployment of the device 2. Aortic diameter at the sinotubular junction \>20 mm and ≤ 38mm 2. Distal Fixation: a length of distal ascending aorta \>5mm proximal to the innominate artery whereby seal and fixation can be achieved (the dissection flap may transcend the arch, but the seal must be achievable within the true lumen of the dissection)
Iliac artery access
Life expectancy greater than 2 years
Suitable arterial anatomy
Absence of systemic disease or allergy that precludes an endovascular repair
Capable of giving informed consent and willingness to comply with follow up schedule
Patient is considered high or prohibitive risk for open surgical repair of the ascending aneurysm or dissection
Must meet ALL of the following:
Innominate artery: 8-22 mm.
Left (or right) common carotid artery: 6-16mm
Left (or right) subclavian artery: 5-20mm
Length of sealing zone ≥ 10mm
Acceptable tortuosity 5. In the setting of an aortic dissection the following criteria must exist:
Life expectancy greater than 2 years
Suitable arterial anatomy
Absence of systemic disease or allergy that precludes an endovascular repair
Capable of giving informed consent and willingness to comply with follow up schedule
Presence of at least one of the following aneurysms is necessary to drive the need for a repair with a fenestrated/branched device:
Outside of the "Indications for Use" for commercially available fenestrated or branched endografts approved for use for the treatment of these aneurysms.
Proximal neck
Iliac Artery
For a straight aorto-aortic prosthesis, distal neck (normal aorta between the aneurysm and iliac bifurcation) ≥ 10 mm in length and ≤ 40 mm in diameter
If a hypogastric branch will be used to treat the common iliac aneurysm
Renal arteries or other visceral vessels arising from the aorta in an orientation that is evident and measurable from cross-sectional imaging (CT or MR)
Visceral branch diameters (for incorporated vessels) between 4 mm - 11 mm at the intended distal sealing site (thus distal to a visceral artery aneurysm in such circumstances).
Greater than 5 mm of proximal visceral branch length to allow for a seal with the mated device, or the ability to exclude an early branch.
In the setting of an aortic dissection the following criteria must exist:
In the setting of a more proximal disease, the repair may be coupled with an arch-branched device, thoracic aortic endograft, or surgical aortic repair - typically performed in a staged fashion
What this trial measures
- All-cause mortality5 years
Freedom from death in perioperative and follow up time period
- Stroke and TIA30 days
Freedom from peri-operative neurologic event
- Aneurysm-related death5 years
Freedom from aneurysm death related to reintervention or incomplete repair