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Safety, Efficacy, Longitudinal Costs and Patient-Centered Outcomes Using a TAAA Debranching Device

NCT03637374 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2022-08-19

Study results available
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Summary

The primary purpose of this study is to assess the use of the TAAA Debranching Stent Graft System to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy, as measured by device safety, effectiveness, costs of delivery of aortic surgery care, and patient quality of life domains. Additionally, the study will assess technical success and treatment success at each follow-up interval.

Conditions

  • Thoracoabdominal Aortic Aneurysm

Interventions

DEVICE

Visceral Manifold and Thoracic Bifurcation

Endovascular stent graft system

DEVICE

Unitary Manifold

Endovascular stent graft system

DEVICE

TAAA Debranching Stent Graft System

Endovascular stent graft system

Sponsors & Collaborators

Principal Investigators

  • James H Black, MD · Johns Hopkins University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-08
Primary Completion
2022-03-21
Completion
2022-06-06
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 NCT03637374 on ClinicalTrials.gov