Branched Thoracic Endovascular Grafts for the Treatment of Thoraco-abdominal Aortic (B-TEVAR)
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|ClinicalTrials.gov Identifier: NCT01874197|
Recruitment Status : Recruiting
First Posted : June 10, 2013
Last Update Posted : September 10, 2018
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 both physician modification of a currently FDA-approved off the shelf thoracic aortic stent graft (COOK Zenith® TX2®) as well as 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 physician modified branched endovascular grafts are a safe and effective method of treating patients with thoraco-abdominal aortic aneurysms.
|Condition or disease||Intervention/treatment||Phase|
|Thoracoabdominal Aortic Aneurysm, Without Rupture||Device: B-TEVAR device||Not Applicable|
A physician modified branched thoracic endograft is a commercially available, off-the-shelf endograft that has been altered at the time of the procedure by creating reinforced fenestrations in the graft through which covered stent grafts can be deployed to preserve blood flow into visceral branch vessels. The graft is deployed on a sterile working table in the operating room. The locations of the fenestrations are marked on the graft according to the pre-procedure measurements. The graft fabric is cut and simultaneously heat sealed using thermal Cautery. These fenestrations/cuffs are marked with medical grade metal markers to facilitate fluoroscopic visualization during the procedure. Furthermore, the fenestrations are reinforced with a short ring of PTFE. This added material is essential as it strengthens the fenestration and creates a ring within which the branch grafts can seal. After the fenestrations have been created, marked, and reinforced, additional metal radio-opaque markers are sewn to the graft to assist in device orientation under fluoroscopy. Additional sutures may be used at that time to constrain the endograft, either in a temporary or permanent fashion to facilitate subsequent deployment. The device is the re-constrained and re-sheathed within the original Zenith® TX2® delivery sheath.
The modified stent graft is then deployed to reline the peri-visceral abdominal aorta. Proximal and distal fixation and seal can be achieved using the modified TX2® device, additional unmodified TX2® devices and/or the Cook Zenith® Flex® device depending on the aortic anatomy.
Once the aortic stent grafts are deployed, the branches are then created. Wires and catheters are used to cross through the reinforced fenestrations into the target visceral arteries. Covered stents are then deployed to extend from the modified aortic graft to the target vessel. The branch stents must create a hemostatic seal with the main endograft as these branches will be constructed within the aneurysm sac. Single or multiple stents may be required for any given branch.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Branched Thoracic Endovascular Grafts for the Treatment of Thoraco-abdominal Aortic Aneurysms: An Investigator-Initiated Study|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||August 2025|
|Estimated Study Completion Date :||August 2028|
Implantation of the B-TEVAR device
Device: B-TEVAR device
Creation and implantation of the Branched Thorcoabdominal aortic anerysm device
- The effectiveness of physician modified endovascular grafts will be determined by evaluating the proportion of patients that achieve Treatment Success [ Time Frame: 12 months post-procedure. ]
- Mortality rates [ Time Frame: 12 months ]
- Technical Success [ Time Frame: 12 months ]Technical Success is defined as successful delivery and deployment of the physician modified graft with preservation of unimpeded flow to those branch vessels intended to be preserved.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01874197
|Contact: Jennifer Cox, MASc||BTEVAR@uw.edu|
|United States, Washington|
|University of Washington/Harborview Medical Center||Recruiting|
|Seattle, Washington, United States, 98104|
|Contact: Matthew Sweet, MD 206-598-1154|
|Contact: Jennifer Cox, MASc BTEVAR@uw.edu|
|Principal Investigator: Matthew P Sweet, MD|
|Principal Investigator:||Matthew P Sweet, MD||University of Washington|