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/NCT01092767
NCT01092767N/ACompleted

Evaluation of the Clinical Performance of the Valiant Thoracic Stent Graft With the Captivia Delivery System for the Endovascular Treatment of Blunt Thoracic Aortic Injuries (RESCUE)

Medtronic Cardiovascular·interventional·Posted Mar 25, 2010·Updated Oct 29, 2021

In Brief

A clinical study evaluating Valiant Thoracic Stent Graft with the Captivia Delivery System for Blunt Thoracic Aortic Injury. Completed, enrolled 50 participants across 25 sites in 2 countries.

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 blunt thoracic aortic injury (BTAI). BTAI is when the aorta has been injured due to traumatic force to the chest area. It is commonly caused by motor vehicle accidents. In most cases it is life threatening and the standard treatment is surgery. Many times when a person has a BTAI they also have other injuries that can affect the results of the surgery. 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 Valiant stent graft would be effective in treating BTAI. A stent graft is a woven polyester tube (graft) supported by a metal frame of strong but flexible nitinol (type of metal) springs (stent) that is placed in the aorta to help seal the injury and keep it from bleeding.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
CollaboratorsMedtronic

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 25, 2010
Enrollment StartApr 1, 2010
Primary CompletionApr 1, 2012
Study CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 16.3 years ago

Interventions

Valiant Thoracic Stent Graft with the Captivia Delivery Systemdevice

All subjects will be implanted with this device