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Visceral Manifold Study for the Repair of TAAA

Primary Purpose

Thoracoabdominal Aortic Aneurysms

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TAAA Debranching Stent Graft System
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracoabdominal Aortic Aneurysms focused on measuring Vascular, Stent, Graft

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Primary Study Arm

Inclusion Criteria:

  • 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

Exclusion Criteria:

General exclusion

  • 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)

Medical exclusion criteria

  • 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
  • Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment
  • Patient has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned < 30 days of the endovascular repair
  • Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina)
  • Systemic or local infection that may increase the risk of endovascular graft infection
  • Baseline creatinine greater than 2.0 mg/dL
  • History of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome)

Anatomical exclusion criteria

  • Thrombus or excessive calcification within the neck of the aneurysm
  • Anatomy that would not allow maintenance of at least one patent hypogastric artery
  • Anatomy that would not allow primary or assisted patency of the left subclavian artery

Expanded Selection Criteria Subjects who fail to meet inclusion criteria for the primary study arm may be enrolled under an expanded selection arm if they meet the following criteria.

Inclusion Criteria

  • Patient that meets the criteria for inclusion in the primary study arm but has one or more of the following criteria which would exclude them from the primary study arm:

    • Minimum branch vessel diameter less than 5 mm
    • Urgent or emergent presentation
    • Patient has a contained rupture
    • Patient has a ruptured aneurysm
    • Patient has a type B dissection (subacute or chronic) in the portion of the aorta intended to be treated
    • Poor performance status including two major system failures (cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular)
    • Baseline creatinine greater than 2.0 mg/dL
    • Anatomy that would not allow for maintenance of at least one hypogastric artery
    • Anatomy that would not allow for primary or assisted patency of the left subclavian artery Or
  • Patient that meets the criteria for inclusion in the primary study arm and:

    • Would not be eligible for the primary study arm per a documented reason other than those outlined above, and
    • Per the opinion of the Principal Investigator, with concurrence of the IRB, alternative therapies are unsatisfactory and the probable risk of using the investigational device is no greater than the probable risk from the disease or condition.

Sites / Locations

  • Tampa General Hospital/ University of South Florida
  • University of South Florida - South Tampa Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Primary study

Expanded selection

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Proportion of subjects with technical success
Proportion of subjects free from individual components of primary safety endpoint
Individual components of primary safety endpoint include: death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke
Proportion of subjects free from paraparesis
Free from paraparesis
Proportion of subjects with treatment success
Treatment success includes freedom from: aneurysm enlargement; aneurysm-related mortality; aneurysm rupture; conversion to open repair; secondary intervention for migration, type I and III endoleaks, device integrity failure (i.e. fracture), and patency-related events (i.e. device stenosis or occlusion and embolic events); renal failure; all-cause mortality; endoleaks; device integrity failure (e.g. fracture); patency-related events (i.e. device stenosis or occlusion and embolic events); other device-related events

Full Information

First Posted
February 24, 2017
Last Updated
July 31, 2023
Sponsor
University of South Florida
Collaborators
Medtronic, Sanford Health
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1. Study Identification

Unique Protocol Identification Number
NCT03075748
Brief Title
Visceral Manifold Study for the Repair of TAAA
Official Title
Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 19, 2017 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
Collaborators
Medtronic, Sanford Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This study is a prospective, single-center, non-randomized, single-arm study to evaluate the therapeutic benefit of the TAAA Debranching Stent Graft System. A total of 15 patients will be enrolled in the study. 10 subjects total will be treated in the primary study arm 5 subjects total will be treated in the expanded selection arm The duration of the Investigation is anticipated as follows: Time to Complete Enrollment: 24 months Subject Follow-up Time: 5 years from last subject enrollment Total Duration Time: 7 years The primary objective of the clinical investigation "Visceral Manifold Study for the repair of thoracoabdominal aortic aneurysms" is to assess the use of the TAAA Debranching Stent Graft System to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent of the study is to assess safety acutely (i.e. freedom from major adverse events (MAE) at 30 days) and preliminary effectiveness (i.e., treatment success and technical success) of the device acutely (i.e., the proportion of treatment group subjects that achieve and maintain treatment success at one year). Additionally, the study will assess technical success and treatment success at each follow-up interval.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracoabdominal Aortic Aneurysms
Keywords
Vascular, Stent, Graft

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Primary study
Arm Type
Experimental
Arm Description
Patients meeting primary inclusion/exclusion criteria will be enrolled in primary study arm and be treated with the TAAA Debranching Stent Graft System.
Arm Title
Expanded selection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
TAAA Debranching Stent Graft System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of subjects free from major adverse events
Description
Primary safety outcome: Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke
Time Frame
30 days
Title
Proportion of subjects with treatment success
Description
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
Time Frame
at 1 year
Secondary Outcome Measure Information:
Title
Proportion of subjects with technical success
Time Frame
5 years
Title
Proportion of subjects free from individual components of primary safety endpoint
Description
Individual components of primary safety endpoint include: death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke
Time Frame
at 30 days
Title
Proportion of subjects free from paraparesis
Description
Free from paraparesis
Time Frame
30 days
Title
Proportion of subjects with treatment success
Description
Treatment success includes freedom from: aneurysm enlargement; aneurysm-related mortality; aneurysm rupture; conversion to open repair; secondary intervention for migration, type I and III endoleaks, device integrity failure (i.e. fracture), and patency-related events (i.e. device stenosis or occlusion and embolic events); renal failure; all-cause mortality; endoleaks; device integrity failure (e.g. fracture); patency-related events (i.e. device stenosis or occlusion and embolic events); other device-related events
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Primary Study Arm Inclusion Criteria: 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 Exclusion Criteria: General exclusion 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) Medical exclusion criteria 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 Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment Patient has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned < 30 days of the endovascular repair Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina) Systemic or local infection that may increase the risk of endovascular graft infection Baseline creatinine greater than 2.0 mg/dL History of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome) Anatomical exclusion criteria Thrombus or excessive calcification within the neck of the aneurysm Anatomy that would not allow maintenance of at least one patent hypogastric artery Anatomy that would not allow primary or assisted patency of the left subclavian artery Expanded Selection Criteria Subjects who fail to meet inclusion criteria for the primary study arm may be enrolled under an expanded selection arm if they meet the following criteria. Inclusion Criteria Patient that meets the criteria for inclusion in the primary study arm but has one or more of the following criteria which would exclude them from the primary study arm: Minimum branch vessel diameter less than 5 mm Urgent or emergent presentation Patient has a contained rupture Patient has a ruptured aneurysm Patient has a type B dissection (subacute or chronic) in the portion of the aorta intended to be treated Poor performance status including two major system failures (cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular) Baseline creatinine greater than 2.0 mg/dL Anatomy that would not allow for maintenance of at least one hypogastric artery Anatomy that would not allow for primary or assisted patency of the left subclavian artery Or Patient that meets the criteria for inclusion in the primary study arm and: Would not be eligible for the primary study arm per a documented reason other than those outlined above, and Per the opinion of the Principal Investigator, with concurrence of the IRB, alternative therapies are unsatisfactory and the probable risk of using the investigational device is no greater than the probable risk from the disease or condition.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murray Shames, MD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampa General Hospital/ University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
University of South Florida - South Tampa Campus
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be shared with Sanford Health
Citations:
PubMed Identifier
24997805
Citation
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.
Results Reference
result
PubMed Identifier
25015113
Citation
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.
Results Reference
result
PubMed Identifier
24184461
Citation
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.
Results Reference
result
PubMed Identifier
20303692
Citation
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.
Results Reference
result
PubMed Identifier
19958984
Citation
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.
Results Reference
result
PubMed Identifier
21925826
Citation
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.
Results Reference
result

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Visceral Manifold Study for the Repair of TAAA

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