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

Not Applicable

Completed

• Conditions: Aortic Dissection

• Registration Number: NCT01114724
• Lead Sponsor: Medtronic Cardiovascular

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-26
• Study First Submitted QC: 2010-04-29
• Study Start: 2010-05
• Study First Posted: 2010-05-03
• Primary Completion: 2013-05
• Results First Submitted: 2014-05-30
• Results First Submitted QC: 2014-05-30
• Results First Posted: 2014-07-03
• Study Completion: 2017-10
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
All Cause Mortality.	Up to 30 days after the stent graft implant.

Secondary Outcome Measures

Name	Time	Method
All-cause Mortality	at 12 months
Subjects With Coverage of Primary Tear	At implant
Subjects With Secondary Endovascular Procedures	Through12 months
Aortic Remodeling: Subjects With Partial/Complete False Lumen Thrombosis Over the Stented Segment	At 6 months
Subjects With Successful Delivery and Deployment of the Device.	At implant.
Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft	at 12 months
Aortic Remodeling: Subjects With Complete/Partial Thrombosis of the False Lumen Over the Stented Segment	At 12 months
Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft	at 12 months
Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events.	at 12 months
Aortic Rupture	Within 12 months

Trial Locations

Locations (17)

USC Keck School of Medicine; 🇺🇸 Los Angeles, California, United States

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Harbor UCLA; 🇺🇸 Torrance, California, United States

Washington Hospital D.C.; 🇺🇸 Washington, District of Columbia, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Northwestern Memorial; 🇺🇸 Chicago, Illinois, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

New York Presbyterian Weill Cornell; 🇺🇸 New York, New York, United States

Novant Health Heart and Vascular Institute; 🇺🇸 Charlotte, North Carolina, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

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