NCT03075748|Active Not RecruitingDMCFDA Device
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Sponsor study identifier
interventional
15
1 country
2
Study Start
December 19, 2017
Actual (reported)Primary Completion
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The outcomes from prior clinical evaluation of the study device, including successfully treating 99% (84/85) of the intended target vessels and 96% (27/28) limb patency observed at one year, demonstrate the potential benefits of the device. When contrasted with open repair's significant complication rates and branch fenestrated device's significant anatomic and logistic limitations, the potential risk of the proposed novel graft does not outweigh the potential benefit of widened anatomic availability and improved patency rates. Given the potential benefits, the investigators feel that it is justified to expose the target patient population to the potential risk. The non-clinical testing performed by Medtronic and the clinical results reported by Sanford Health show adequate safety of the device to support an early feasibility study. The investigators would like to perform an early feasibility study under a defined and controlled protocol to collect prospective preliminary safety and device functionality data. The investigators believe an early feasibility study is most appropriate for this novel approach. The limited sample size allows adequate patient data to be collected under a controlled protocol without exposing a large patient population to the risk associated with a novel device design.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 24, 2017
Actual (reported)March 9, 2017
Actual (reported)December 19, 2017
Actual (reported)December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Proportion of subjects free from major adverse events
Primary safety outcome: Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke
30 days
Proportion of subjects with treatment success
Primary effectiveness outcome: Treatment success is defined as a composite of technical success and freedom from the following: aneurysm enlargement, aneurysm rupture, aneurysm-related mortality, conversion to open repair, secondary intervention for migration, Type I and III endoleaks, device integrity failure, and patency-related events
at 1 year
Proportion of subjects with technical success
5 years
Proportion of subjects free from individual components of primary safety endpoint
at 30 days
Proportion of subjects free from paraparesis
30 days
Proportion of subjects with treatment success
5 years
Patients meeting primary inclusion/exclusion criteria will be enrolled in primary study arm and be treated with the TAAA Debranching Stent Graft System.
Patients who fail to meet inclusion criteria for the primary study arm may be enrolled under the expanded selection arm and be treated with the TAAA Debranching Stent Graft System.
The TAAA Debranching Stent Graft System is made up of two main body components and makes use of several off-the-shelf FDA-approved stent graft components. The two custom main body grafts are the thoracic bifurcation and the visceral manifold. The thoracic bifurcation is deployed in the thoracic aorta and provides the proximal seal for the device. The two limbs of the thoracic bifurcation allows for continued aortic flow while deploying the visceral segment. The visceral manifold is deployed within the larger 20 mm limb of the thoracic bifurcation to set the stage for the visceral debranching. The branches of the visceral manifold extend to the visceral vessel with the use of covered bridging stents and provide distal seal of the manifold.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Tampa General Hospital/ University of South Florida
Tampa, Florida, 33606, United States
University of South Florida - South Tampa Campus
Tampa, Florida, 33606, United States
Anderson J, Nykamp M, Danielson L, Remund T, Kelly PW. A novel endovascular debranching technique using physician-assembled endografts for repair of thoracoabdominal aneurysms. J Vasc Surg. 2014 Nov;60(5):1177-1184. doi: 10.1016/j.jvs.2014.05.090. Epub 2014 Jul 3.
Anderson J, Nykamp M, Remund T, Kelly P. Complete endovascular debranching of the aortic arch: A report of two cases. Vascular. 2015 Jun;23(3):310-5. doi: 10.1177/1708538114542174. Epub 2014 Jul 11.
Murray Shames, MD
University of South Florida
First Submitted
February 24, 2017
First Posted
March 9, 2017
Study Start
December 19, 2017
Actual (reported)Primary Completion
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms
Contact the study team to confirm eligibility.
Danielson L, Anderson J, Nykamp M, Remund T, Kelly P. Treatment of a massive left femoral arteriovenous malformation using an innovative modular hybrid bifurcated stent graft system. Ann Vasc Surg. 2014 May;28(4):1031.e15-20. doi: 10.1016/j.avsg.2013.07.023. Epub 2013 Oct 31.
Narayanan S, Shalhoub J, Karunanithy N, Burfitt N. Primary suture-anastomosis of the Viabahn endoprosthesis to a native artery. J Vasc Surg. 2010 May;51(5):1297-9. doi: 10.1016/j.jvs.2009.12.045. Epub 2010 Mar 19.
Donas KP, Lachat M, Rancic Z, Oberkofler C, Pfammatter T, Guber I, Veith FJ, Mayer D. Early and midterm outcome of a novel technique to simplify the hybrid procedures in the treatment of thoracoabdominal and pararenal aortic aneurysms. J Vasc Surg. 2009 Dec;50(6):1280-4. doi: 10.1016/j.jvs.2009.06.053.
Oderich GS, Fatima J, Gloviczki P. Stent graft modification with mini-cuff reinforced fenestrations for urgent repair of thoracoabdominal aortic aneurysms. J Vasc Surg. 2011 Nov;54(5):1522-6. doi: 10.1016/j.jvs.2011.06.023. Epub 2011 Sep 16.
Study Completion
February 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 22, 2025
Record last verified: 2025-01
De-identified data will be shared with Sanford Health
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Source: ClinicalTrials.gov.
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