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Safety, Efficacy, Longitudinal Costs and Patient-Centered Outcomes Using a TAAA Debranching Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03637374
Recruitment Status : Enrolling by invitation
First Posted : August 20, 2018
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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Brief Summary:
The primary purpose of this study is to assess the use of the TAAA Debranching Stent Graft System to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy, as measured by device safety, effectiveness, costs of delivery of aortic surgery care, and patient quality of life domains. Additionally, the study will assess technical success and treatment success at each follow-up interval.

Condition or disease Intervention/treatment Phase
Thoracoabdominal Aortic Aneurysm Device: Visceral Manifold and Thoracic Bifurcation Device: Unitary Manifold Device: TAAA Debranching Stent Graft System Not Applicable

Detailed Description:
The primary objective of this clinical investigation is to assess the use of the TAAA Debranching Stent Graft System to repair thoracoabdominal aortic aneurysms. While surgery remains a standard treatment for complex abdominal and thoracoabdominal aneurysms (TAAA), the tolerance of some patients to recover from such extensive and invasive open aortic reconstructions is poor. Endovascular repair may offer the opportunity to reduce patient risk with less invasive approaches, improve quality of life, and serve to reduce the cost burden. The primary technical safety endpoint is freedom from major adverse events (MAE) at 30 days or during hospitalization if this exceeds 30 days. The primary effectiveness endpoint is the proportion of study subjects with treatment success at 1 year.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of the Safety, Efficacy, Longitudinal Costs and Patient-Centered Outcomes Using a TAAA Debranching Device
Actual Study Start Date : September 8, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Primary Study Arm
The TAAA Debranching Stent Graft System is comprised of two investigational devices including the Visceral Manifold and Thoracic Bifurcation and the unitary manifold. The thoracic bifurcation and the visceral manifold as well as the unitary manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.
 Device: Visceral Manifold and Thoracic Bifurcation
Endovascular stent graft system

Device: Unitary Manifold
Endovascular stent graft system

Device: TAAA Debranching Stent Graft System
Endovascular stent graft system
Expanded Selection Arm
The Expanded Selection Arm will be treated the same as those in the Primary Study Arm. Your doctor will determine what arm you are in. TAAA Debranching Stent Graft System is comprised of two investigational devices including the Visceral Manifold and Thoracic Bifurcation and the unitary manifold. The thoracic bifurcation and the visceral manifold as well as the unitary manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.
 Device: Visceral Manifold and Thoracic Bifurcation
Endovascular stent graft system

Device: Unitary Manifold
Endovascular stent graft system

Device: TAAA Debranching Stent Graft System
Endovascular stent graft system


Outcome Measures
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Primary Outcome Measures :
  1. Freedom from major adverse events (MAEs) at 30 days [ Time Frame: 30 days ]
    Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke.


Secondary Outcome Measures :
  1. Treatment success at 1 year [ Time Frame: 1 year ]

    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



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Modified 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

Other inclusion criteria:

  • 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 healthy/nondiseased tissue (including previously placed graft material) (neck) distal to the left subclavian artery (LSA) diameter in the range of 26-42 mm
    • ≥2.5cm of surgical graft distal to the left subclavian artery (LSA) diameter in the range of 26-42mm.
    • 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 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
  • Patency of the four major visceral vessels (SMA, celiac, right renal, left renal)
  • Age: ≥ 18 years old
  • Life expectancy: > 1 year

Exclusion Criteria

General exclusion

  • Patient is a good candidate for and elects 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 investigational device exemption (IDE) at the investigational site
  • Unwilling to comply with the follow-up schedule
  • Inability or refusal to give informed consent by patient or legal representative
  • Patient is pregnant or breastfeeding
  • Patient has a contained rupture
  • Patient has a ruptured aneurysm
  • Patient has a dissection in the treated portion of the aorta
  • Obstructive stenting of any or all of the visceral vessels

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
  • Branch stenosis ≥ 70%
  • 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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT03637374


Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: James H Black, MD Johns Hopkins University
More Information
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Publications:

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03637374    
Other Study ID Numbers: IRB00075706
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Johns Hopkins University:
aortic aneurysm
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases