CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Valiant Thoracic Stent Graft with the Captivia Delivery Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01114724
NCT01114724N/ACompleted

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 Cardiovascular·interventional·Posted May 3, 2010·Updated Oct 29, 2021

In Brief

A clinical study evaluating Valiant Thoracic Stent Graft with the Captivia Delivery System for Aortic Dissection. Completed, enrolled 50 participants across 17 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsMedtronic

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 3, 2010
Enrollment StartMay 1, 2010
Primary CompletionMay 1, 2013
Study CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 16.2 years ago

Interventions

Valiant Thoracic Stent Graft with the Captivia Delivery Systemdevice

All subjects will be implanted with this device