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Thoracoabdominal Aortic AneurysmNCT04009512

Valiant: Endovascular Repair of Thoracoabdominal Aortic Aneurysms

A study testing Valiant Thoracoabdominal Stent Graft System in people with Thoracoabdominal Aortic Aneurysm, run by Matthew Eagleton.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The primary objective of this study is to assess the use of the thoracic bifurcation and the visceral manifold devices in the repair thoracoabdominal aortic aneurysms in patients with appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thoracoabdominal Aortic Aneurysm
What is being tested?
Valiant Thoracoabdominal Stent Graft System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
6 Oct 2020to 9 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Primary 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 or equal to 4.5 cm
Show all 14Show fewer
  • 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 nonaneurysmal aortic segment including previously placed graft material (neck) distal to the left subclavian artery (LSA) and a 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
  • 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

Who cannot join

  • Primary Arm Exclusion criteria
  • 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 by patient or legal representative
Show all 46Show fewer
  • 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 (including but not limited to 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 or equal to 2.0 mg/dL
  • History of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome)
  • Prior aneurysm repair that would involve relining of the previously placed graft material requiring placement of the investigational system in a landing zone that expands beyond any limits of the previously placed graft material
  • Anatomical exclusion criteria
  • Minimum branch vessel diameter less than 5 mm
  • Thrombus or excessive calcification within the proximal aortic neck
  • 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 Use Arm Inclusion Criteria
  • Patient that meet 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:
  • An expanded use arm of the study will broaden inclusion criteria to include patients with the following :
  • Minimum branch vessel diameter <5mm
  • 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 (including but not limited to cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular)
  • Baseline creatinine greater than or equal to 2.0 mg/dL
  • Anatomy that does not allow maintenance of at least one hypogastric artery
  • Anatomy that does not allow primary or assisted patency of the left subclavian artery
  • Prior aneurysm repair that would involve relining of the previously placed graft material requiring placement of the investigational system in a landing zone that expands beyond any limits of the previously placed graft material
  • Obstructive stenting of any or all of the visceral vessels
  • 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.

About this study

Official title: Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms

The primary objective of this study is to assess the use of the thoracic bifurcation and the visceral manifold devices in the repair thoracoabdominal aortic aneurysms in patients with appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device. Additionally, the study will assess technical success and treatment success at each follow-up interval.

Read the detailed description

The primary objective is to assess the use of the thoracic bifurcation and the visceral manifold stent graft system to repair thoracoabdominal aortic aneurysms in patients with appropriate anatomy. The primary intent of the study is to assess safety (i.e. freedom from major adverse events (MAE) at 30 days) and preliminary effectiveness (i.e., treatment success and technical success) of the device (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.

Being tested
Valiant Thoracoabdominal Stent Graft System
Medical subject headings
Aortic Aneurysm, Thoracoabdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Valiant Thoracoabdominal Stent Graft SystemDevice

    This system of devices works to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments in patients with thoracoabdominal aneurysms.

Study groups in NCT04009512
Study groupRoleWhat they receive
Primary Study ArmExperimentalThe Valiant Thoracoabdominal Stent Graft System is comprised of two investigational devices including the Thoracic Bifurcate and the Visceral Manifold. These devices work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.
Receives: Device: Valiant Thoracoabdominal Stent Graft System
Expanded Use ArmExperimentalThe Valiant Thoracoabdominal Stent Graft System is comprised of two investigational devices including the Thoracic Bifurcate and the Visceral Manifold. These devices work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments. The expanded use arm provides broaden inclusion criteria to include select patients excluded from the primary study arm.
Receives: Device: Valiant Thoracoabdominal Stent Graft System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Freedom from MAEs (at 30 Days)

    Major Adverse Events include: all-cause mortality within 30 days of the procedure, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke.

    Measured: 30 Days post- procedure

  2. Preliminary Effectiveness (treatment and technical success)

    Treatment success is defined as a composite of technical success and freedom from the following:

    • Aneurysm enlargement i.e., >5mm as compared to any previous CT measure using orthogonal (i.e., perpendicular to the centerline) measurements
    • Aneurysm rupture
    • Aneurysm-related mortality
    • Conversion to open repair
    • Secondary intervention for migration, Type I and III endoleaks, device integrity failure (e.g., fracture), and patency-related events (i.e., device component stenosis or occlusion and embolic events)

    Measured: 1- year post-procedure

Secondary outcomes (2)

  1. Technical Success

    Technical success and the individual components of technical success include:

    • Successful delivery
    • Deployment at the intended implantation site
    • Patency of all endovascular graft and stent components
    • Absence of device deformations requiring unplanned placement of an additional device
    • Absence of inadvertent covering of aortic branch vessels
    • Successful withdrawal

    Measured: at each follow-up interval (five years)

  2. Treatment Success

    Treatment success and the individual components of treatment success including freedom from the following at each follow-up interval:

    • 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

    Measured: at each follow-up interval (five years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2019
  2. Study start6 Oct 2020
  3. Primary completion9 Mar 2022
  4. Study completion9 Mar 2022

Why it stopped: Device was no longer available.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04009512
Sponsor's protocol ID
2019P001299
Status last verified
Oct 2026
First submitted
24 Jun 2019
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Valiant Thoracoabdominal Stent Graft System in people with Thoracoabdominal Aortic Aneurysm, run by Matthew Eagleton.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from MAEs (at 30 Days) (time frame: 30 Days post- procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04009512.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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Clinical Trial NCT04009512 | AzTrials