Valiant® Thoracic Stent Graft With the Captivia Delivery System. Evaluation of 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

Medtronic Cardiovascular17 sites in 1 country50 target enrollmentMay 2010

ConditionsAortic Dissection

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Dissection
Sponsor: Medtronic Cardiovascular
Enrollment: 50
Locations: 17
Primary Endpoint: All Cause Mortality.
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2010

End Date

October 2017

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medtronic Cardiovascular

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

All Cause Mortality.

Time Frame: Up to 30 days after the stent graft implant.

Secondary Outcomes

All-cause Mortality(at 12 months)
Subjects With Successful Delivery and Deployment of the Device.(At implant.)
Subjects With Coverage of Primary Tear(At implant)
Aortic Rupture(Within 12 months)
Subjects With Secondary Endovascular Procedures(Through12 months)
Aortic Remodeling: Subjects With Partial/Complete False Lumen Thrombosis Over the Stented Segment(At 6 months)
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)