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

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

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

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 days

Number of participants with freedom from early death at 30-days post-procedure

Outcome measures

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

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

Sarah Hale

Baylor Scott and White Resarch Institute

Phone: 469-814-4845

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place