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Visceral Manifold and Unitary Device Study for the Repair of Thoracoabdominal Aortic Aneurysms

NCT02294435 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2024-12-16

No results posted yet for this study

Summary

The primary objective of the Visceral Manifold and Unitary Device Study is to assess the use of the thoracic bifurcation and the visceral manifold or the unitary device to repair thoracoabdominal aortic aneurysms in patients having 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.

Conditions

  • Thoracoabdominal Aneurysms

Interventions

DEVICE

Visceral Manifold and Thoracic Bifurcation

Visceral Manifold and Thoracic Bifurcation Endovascular stent graft system

DEVICE

Unitary Manifold

Unitary Manifold Endovascular stent graft system

Sponsors & Collaborators

  • Dakota Vascular

    collaborator OTHER

  • Sanford Health

    lead OTHER

Principal Investigators

  • Patrick Kelly, MD

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2024-01-31
Completion
2029-12-31
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 NCT02294435 on ClinicalTrials.gov