Visceral Manifold Study for the Repair of TAAA

NCT03075748 | Active Not Recruiting DMC FDA Device

• 1 other identifier: IP-01-001 Visceral Manifold
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Thoracoabdominal Aortic Aneurysms

Keywords

Vascular; Stent; Graft

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• 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

Study Arms (2)

Primary study

EXPERIMENTAL

Patients meeting primary inclusion/exclusion criteria will be enrolled in primary study arm and be treated with the TAAA Debranching Stent Graft System.

Device: TAAA Debranching Stent Graft System

Expanded selection

EXPERIMENTAL

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.

Device: TAAA Debranching Stent Graft System

Interventions

TAAA Debranching Stent Graft System DEVICE

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.

Expanded selection; Primary study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A patient may be entered into the study if the patient has at least one of the following:
• An aneurysm with a maximum diameter of \> 5.5 cm or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements
• Aneurysm with a history of growth \> 0.5 cm in 6 months
• Saccular aneurysm deemed at significant risk for rupture
• Symptomatic aneurysm greater than 4.5 cm
• Axillary or brachial and iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit
• Proximal landing zone for the thoracic bifurcation stent graft that has:
• ≥ 2.5 cm of nonaneurysmal aortic segment including previously placed graft material (neck) distal to the left subclavian artery (LSA) diameter in the range of 26-42 mm
• Adequate distance from the celiac artery, in order to accommodate cannulation from the antegrade access point when considering the total deployed length of the thoracic bifurcation and visceral manifold
• Minimum branch vessel diameter greater than 5 mm
• Iliac artery or aortic distal fixation site, including both native tissue and previously placed graft, greater than or equal to 15 mm in length and diameter in the range of 8 - 25 mm
• Age: ≥ 18 years old
• Life expectancy: \> 1 year

You may not qualify if:

• Patient is a good candidate for and elects for open surgical repair
• Can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis
• Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site
• Unwilling to comply with the follow-up schedule
• Inability or refusal to give informed consent
• Urgent or emergent presentation
• Patient is pregnant or breastfeeding
• Patient has a contained rupture
• Patient has a ruptured aneurysm
• Patient has a dissection in the portion of the aorta intended to be treated
• Obstructive stenting of any or all of the visceral vessels
• Poor performance status including two major system failures (cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular)
• Known sensitivities or allergies to the materials of construction of the devices, including nitinol (Nickel: Titanium), polyester, platinum-iridium, polytetrafluoroethylene (PTFE), platinum, gold, polyethylene, or stainless steel.
• Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed
• Uncorrectable coagulopathy

Sponsors & Collaborators

• University of South Florida: lead
• Medtronic: collaborator
• Sanford Health: collaborator

Study Sites (2)

Tampa General Hospital/ University of South Florida

Tampa, Florida, 33606, United States

Location

University of South Florida - South Tampa Campus

Tampa, Florida, 33606, United States

Location

Related Publications (6)

• 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.

  PMID: 24997805 RESULT

• 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.

  PMID: 25015113 RESULT

• 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.

  PMID: 24184461 RESULT

• 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.

  PMID: 20303692 RESULT

• 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.

  PMID: 19958984 RESULT

• 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.

  PMID: 21925826 RESULT

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Abdominal; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Murray Shames, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: March 9, 2017
• Study Start: December 19, 2017
• Primary Completion: December 1, 2025
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (2)