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Study to Evaluate the Clinical Performance of the Valiant Thoracic Stent Graft With the Captivia Delivery System (Valiant Captivia) for the Treatment of Acute, Complicated Type B Aortic Dissections

NCT01114724 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-10-29

Study results available
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Summary

The purpose of this study is to determine if the Valiant stent graft is safe and effective in treating patients who have a thoracic dissection. A thoracic dissection is a tear in the wall of the aorta, that causes blood to flow between the layers of the aorta and force the layers apart (dissect). This condition is a medical emergency and can quickly lead to death. Since stent grafting has been an effective way to treat other aortic conditions such as aneurysms (bulge in aorta wall), it is believed that the device would be effective in treating dissections. Information will be collected on the performance of the device for 5 years.

Conditions

  • Aortic Dissection

Interventions

DEVICE

Valiant Thoracic Stent Graft with the Captivia Delivery System

All subjects will be implanted with this device

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Medtronic Cardiovascular

    lead INDUSTRY

Principal Investigators

  • Joseph E. Bavaria, M.D. · Univ. of Pennsylvania Health System

  • W. Anthony Lee, M.D., F.A.C.S · Lynn Heart Institute, Boca Raton Community Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2013-05-31
Completion
2017-10-31

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 NCT01114724 on ClinicalTrials.gov