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Endovascular Repair of Descending ThoracoAbdominal Aortic Pathologies Using Physician Modified Endovascular Prosthesis

NCT02524834 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-05-06

No results posted yet for this study

Summary

This is an early feasibility study that investigates the outcome of selected patients with complex thoracoabdominal aortic lesions who are suitable for endovascular (within the vessel) repair with a physician-modified Medtronic Thoracic Valiant stent graft. The Medtronic Valiant System includes a Valiant Thoracic Stent Graft, a self-expanding, tubular end prosthesis which is modified/customized by the Investigators to fit the patient's anatomy. The device is constructed by making a taper in the larger proximal thoracic device and attaching it to a smaller distal thoracic device. The Viabahn branches for the visceral vessels are sutured to holes made in the tapered section. The modified Valiant stent graft is advanced to the lesion site endoluminally via the iliac/femoral artery. Access for delivery of extensions to the device will be delivered through the left subclavian artery. Upon deployment, the stent graft self-expands at the target location, where it is designed to exclude the lesion by restoring blood flow through the stent graft lumen.

Conditions

  • Aortic Disease

Interventions

PROCEDURE

Exclusion of thoracoabdominal lesion

Endovascular repair of thoracoabdominal lesion with a physician modified Medtronic Valiant stent graft

DEVICE

Endovascular Device Implant

Endovascular repair of thoracoabdominal lesion with a physician modified Medtronic Valiant stent graft

Sponsors & Collaborators

  • Long Beach Memorial Medical Center

    collaborator OTHER

  • Rodney A. White, MD

    lead OTHER

Principal Investigators

  • Rodney A White, MD · Medical Director, Vascular Surgery Long Beach Memorial Heart & Vascular Institute, Long Beach, CA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-29
Primary Completion
2025-02-18
Completion
2025-02-18
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT02524834 on ClinicalTrials.gov