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Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms

NCT03246126 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-04-10

Study results available
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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

Interventions

DEVICE

Valiant™Thoracoabdominal Stent Graft System

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.

Sponsors & Collaborators

Principal Investigators

  • Thomas Maldonado · NYU Langone Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2023-06-07
Completion
2023-06-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03246126 on ClinicalTrials.gov