Branched Thoracic Endovascular Grafts for the Treatment of Thoraco-abdominal Aortic (B-TEVAR)
An investigator-initiated, prospective, consecutively enrolling, non-randomized single institution clinical evaluation of the safety and effectiveness of physician modification of a currently FDA-approved off the shelf thoracic aortic stent graft (COOK Zenith® TX2®) to preserve branch vessels when used in the treatment of patients with thoraco-abdominal aortic aneurysms.
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Branched Thoracic Endovascular Grafts for the Treatment of Thoraco-abdominal Aortic Aneurysms: An Investigator-Initiated Study|
- 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. ] [ Designated as safety issue: Yes ]
- Mortality rates [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Technical Success [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||August 2023|
|Estimated Primary Completion Date:||August 2018 (Final data collection date for primary outcome measure)|
Implantation of the B-TEVAR device
Device: B-TEVAR device
Creation and implantation of the Branched Thorcoabdominal aortic anerysm device
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® or Endologix AFX™ devices 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.
|Contact: Ms Billi Tatum, RN,CCRCemail@example.com|
|United States, Washington|
|University of Washington/Harborview Medical Center||Recruiting|
|Seattle, Washington, United States, 98104|
|Contact: Matthew Sweet, MD 206-598-1154|
|Contact: Billi Tatum, RN,CCRC 206.744.3369 firstname.lastname@example.org|
|Principal Investigator: Matthew P Sweet, MD|
|Principal Investigator:||Matthew P Sweet, MD||University of Washington|