Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms

NCT03246126 | Completed Results FDA Device

• 1 other identifier: 16-01441
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the use of an investigational device called the ValiantTM Visceral Manifold Thoracoabdominal Stent Graft System for the repair of thoracoabdominal aortic aneurysms (TAAA), which is a balloon-like bulge in the aorta (major artery leading away from your heart) that originates in your chest and extends to your abdomen and also includes the branch arteries that supply blood to the liver, spleen, intestine, kidneys and other organs in your abdomen. The word "investigational" means the device is still being tested and is not approved by the Food and Drug Administration (FDA) for sale in the United States.

Conditions

Thoracoabdominal Aortic Aneurysms

Outcome Measures

Primary Outcomes (2)

• Freedom From Major Adverse Events (MAE) at Day 30

  Freedom from MAE is defined as the number of participants who have not experienced a major adverse event (including death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke) at 30 days.

  Up to Day 30

• Number of Participants Who Achieve Technical Success

  Technical success is defined as successful access of the aneurysm site and deployment of the Visceral Manifold investigational devices in intended locations.

  Up to Year 1

Secondary Outcomes (1)

• Freedom From Paraplegia at Day 30

  Up to Day 30

Study Arms (2)

Primary Arm: Treatment with Valiant Thoracoabdominal Stent Graft System

EXPERIMENTAL

The implantation of the Valiant Thoracoabdominal Stent Graft System is conducted under fluoroscopic/angiographic guidance.

Device: Valiant™Thoracoabdominal Stent Graft System

Expanded Use Arm: Treatment with Valiant Thoracoabdominal Stent Graft System

EXPERIMENTAL

The implantation of the Valiant Thoracoabdominal Stent Graft System is conducted under fluoroscopic/angiographic guidance.

Device: Valiant™Thoracoabdominal Stent Graft System

Interventions

Valiant™Thoracoabdominal Stent Graft System DEVICE

The Visceral Manifold System is comprised of the Thoracic Bifurcation and Visceral Manifold to treat a thoracoabdominal aortic aneurysm or TAAA. The experimental procedure to implant the stent graft will be done in an operating room and will last anywhere from four to eight hours, but may take longer.

Also known as: Endurant Stent Graft System

Expanded Use Arm: Treatment with Valiant Thoracoabdominal Stent Graft System; Primary Arm: Treatment with Valiant Thoracoabdominal Stent Graft System

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 or equal to 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: (a) ≥ 2.5 cm of nonaneurysmal aortic segment including previously placed graft material (neck) distal to the left subclavian artery (LSA); (b) Diameter in the range of 26-42 mm; (c) 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
• Life expectancy: \> 1 year
• 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 (cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular)

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 by patient or legal representative
• 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)
• 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
• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Thomas Maldonado
• Organization: NYU Langone Health

Thomas.Maldonado@nyulangone.org

212-263-7311

Study Officials

• Thomas Maldonado

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: August 2, 2017
• First Posted: August 11, 2017
• Study Start: November 1, 2017
• Primary Completion: June 7, 2023
• Study Completion: June 7, 2023
• Last Updated: April 10, 2024
• Results First Posted: April 10, 2024

Record last verified: 2024-03

Locations

US (1)