Trial Outcomes & Findings for Feasibility of Endovascular Repair of Ascending Aortic Pathologies (NCT NCT03322033)
NCT ID: NCT03322033
Last Updated: 2026-03-02
Results Overview
Number of participants with freedom from early death at 30-days post-procedure
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
1 participants
Primary outcome timeframe
30 days
Results posted on
2026-03-02
Participant Flow
Participant milestones
| Measure |
Type A Dissection
High risk subjects with ascending thoracic aortic pathologies including type A aortic dissection who are suitable for endovascular repair
Valiant PS-IDE Stent Graft: Medtronic Valiant PS-IDE Stent Graft System with the Captivia Delivery System
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Type A Dissection
High risk subjects with ascending thoracic aortic pathologies including type A aortic dissection who are suitable for endovascular repair
Valiant PS-IDE Stent Graft: Medtronic Valiant PS-IDE Stent Graft System with the Captivia Delivery System
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Feasibility of Endovascular Repair of Ascending Aortic Pathologies
Baseline characteristics by cohort
| Measure |
Type A Dissection
n=1 Participants
High risk subjects with ascending thoracic aortic pathologies including type A aortic dissection who are suitable for endovascular repair
Valiant PS-IDE Stent Graft: Medtronic Valiant PS-IDE Stent Graft System with the Captivia Delivery System
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=41 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=41 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=41 Participants
|
PRIMARY outcome
Timeframe: 30 daysNumber of participants with freedom from early death at 30-days post-procedure
Outcome measures
| Measure |
Type A Dissection
n=1 Participants
High risk subjects with ascending thoracic aortic pathologies including type A aortic dissection who are suitable for endovascular repair
Valiant PS-IDE Stent Graft: Medtronic Valiant PS-IDE Stent Graft System with the Captivia Delivery System
|
|---|---|
|
Number of Participants With Freedom From Early Death
|
1 Participants
|
Adverse Events
Type A Dissection
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Type A Dissection
n=1 participants at risk
High risk subjects with ascending thoracic aortic pathologies including type A aortic dissection who are suitable for endovascular repair
Valiant PS-IDE Stent Graft: Medtronic Valiant PS-IDE Stent Graft System with the Captivia Delivery System
|
|---|---|
|
Surgical and medical procedures
Type 1B endoleak
|
100.0%
1/1 • Number of events 1 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place