Trial Outcomes & Findings for Study to Determine if the Valiant Stent Graft is Safe and Effective in Treating Patients Who Have a Blunt Thoracic Aortic Injury (NCT NCT01092767)

NCT ID: NCT01092767

Last Updated: 2021-10-29

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

30 days

Results posted on

2021-10-29

Participant Flow

A total of 25 investigational sites were activated and allowed to enroll in the RESCUE study in the US and Canada. A total of 50 subjects were enrolled at 20 of the 25 activated investigational sites, with the first enrollment on April 14, 2010 and the final enrollment on January 17, 2012.

All 50 subjects enrolled were implanted with the device (Valiant Thoracic Stent Graft with the Captivia Delivery System ).

Participant milestones

Participant milestones
Measure	Valiant Thoracic Stent Graft With the Captivia Delivery System Valiant Thoracic Stent Graft with the Captivia Delivery System : All subjects will be implanted with this device
Overall Study STARTED	50
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Determine if the Valiant Stent Graft is Safe and Effective in Treating Patients Who Have a Blunt Thoracic Aortic Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Valiant Thoracic Stent Graft With the Captivia Delivery System n=50 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	40.7 years STANDARD_DEVIATION 17.4 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants
Region of Enrollment United States	48 participants n=5 Participants
Region of Enrollment Canada	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	Valiant Thoracic Stent Graft With the Captivia Delivery System n=50 Participants Valiant Thoracic Stent Graft with the Captivia Delivery System : All subjects will be implanted with this device
All-cause Mortality Within 30-days of the Index Procedure	4 participants

Adverse Events

1. Rescue

Serious events: 8 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	1. Rescue n=50 participants at risk Rescue
Cardiac disorders Arrhythmia	2.0% 1/50 • Number of events 1 • 12 months
Infections and infestations Infection	0.00% 0/50 • 12 months
Injury, poisoning and procedural complications Multiple Injuries	2.0% 1/50 • Number of events 1 • 12 months
Injury, poisoning and procedural complications Traumatic Brain Injury	2.0% 1/50 • Number of events 1 • 12 months
Nervous system disorders Anoxic Encephalopathy	2.0% 1/50 • Number of events 1 • 12 months
Respiratory, thoracic and mediastinal disorders Haemothorax	2.0% 1/50 • Number of events 1 • 12 months
Vascular disorders Femoral Artery Dissection	2.0% 1/50 • Number of events 1 • 12 months
Vascular disorders Intermittent Claudication	2.0% 1/50 • Number of events 1 • 12 months
Vascular disorders Peripheral Ischaemia	2.0% 1/50 • Number of events 1 • 12 months

Other adverse events

Adverse event data not reported

Additional Information

Laura Regan, MPH - Study Lead

Medtronic, Inc., Aortic and Peripheral Vascular

Phone: 707-591-2743

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Principal Investigator (PI) and institution agree not to publish the results of the study until after the earliest of the following: a)conclusion of the study, b)the early termination of the study, c)at discretion and approval of the sponsor, or d)after sponsor confirms there will be no multicenter study publication, whichever occurs first. PI and institution further agree to submit to sponsor copies of any proposed publication or public presentation at least sixty days before dissemination.
Publication restrictions are in place

Restriction type: OTHER