Trial Outcomes & Findings for Safety and Efficacy of Valiant Mona LSA Stent Graft System (NCT NCT01839695)
NCT ID: NCT01839695
Last Updated: 2023-07-03
Results Overview
Major Adverse Events is a composite endpoint that includes Aneurysm Related Mortality (ARM), Stroke, Paraplegia, and Left Arm/Hand Ischemia.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
1 month
Results posted on
2023-07-03
Participant Flow
Participant milestones
| Measure |
Valiant Mona LSA Stent Graft System
TEVAR procedure using Medtronic Stent Graft\>
\> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Valiant Mona LSA Stent Graft System
Baseline characteristics by cohort
| Measure |
Valiant Mona LSA Stent Graft System
n=9 Participants
TEVAR procedure using Medtronic Stent Graft\>
\> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device
|
|---|---|
|
Age, Continuous
|
72.89 years
STANDARD_DEVIATION 7.61 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Includes active subjects in the ITT population at 30 days post-index procedure.
Major Adverse Events is a composite endpoint that includes Aneurysm Related Mortality (ARM), Stroke, Paraplegia, and Left Arm/Hand Ischemia.
Outcome measures
| Measure |
Valiant Mona LSA Stent Graft System
n=9 Participants
TEVAR procedure using Medtronic Stent Graft \>
\> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device
|
|---|---|
|
Primary Safety Observation - Rate of Major Adverse Events (MAEs)
|
3 participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Based on the number of ITT subject with evaluable data, subjects were considered unevaluable for treatment success if the 30 day imaging was unable to assess patency of the MSG and BSG. One subject completed CT imaging at discharge, which was not repeated at the 30 day visit, and, therefore, was not considered evaluable for this assessment.
Treatment success which is defined as technical success (successful delivery and deployment of the stent graft in the planned location with no unintentional coverage of other vessels, assessed intraoperatively, and the removal of the delivery system) and successful exclusion of the aneurysm while maintaining patency of the MSG and BSG at the 30 day visit.
Outcome measures
| Measure |
Valiant Mona LSA Stent Graft System
n=8 Participants
TEVAR procedure using Medtronic Stent Graft \>
\> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device
|
|---|---|
|
Primary Effectiveness Observation
|
8 participants
|
Adverse Events
Valiant Mona LSA Stent Graft System
Serious events: 7 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Valiant Mona LSA Stent Graft System
n=9 participants at risk
TEVAR procedure using Medtronic Stent Graft \>
\> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
1/9 • Number of events 1 • Through 30 days
Investigators are required to assess for adverse events at each follow-up timepoint, including discharge, 30 days, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months. Per protocol, all adverse events are required to be reported, regardless of relationship.
|
|
Cardiac disorders
Cardiac Failure
|
11.1%
1/9 • Number of events 1 • Through 30 days
Investigators are required to assess for adverse events at each follow-up timepoint, including discharge, 30 days, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months. Per protocol, all adverse events are required to be reported, regardless of relationship.
|
|
Cardiac disorders
Cardiovascular Deconditioning
|
11.1%
1/9 • Number of events 1 • Through 30 days
Investigators are required to assess for adverse events at each follow-up timepoint, including discharge, 30 days, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months. Per protocol, all adverse events are required to be reported, regardless of relationship.
|
|
Gastrointestinal disorders
Abdominal Hernia
|
11.1%
1/9 • Number of events 1 • Through 30 days
Investigators are required to assess for adverse events at each follow-up timepoint, including discharge, 30 days, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months. Per protocol, all adverse events are required to be reported, regardless of relationship.
|
|
General disorders
Pyrexia
|
11.1%
1/9 • Number of events 1 • Through 30 days
Investigators are required to assess for adverse events at each follow-up timepoint, including discharge, 30 days, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months. Per protocol, all adverse events are required to be reported, regardless of relationship.
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
11.1%
1/9 • Number of events 1 • Through 30 days
Investigators are required to assess for adverse events at each follow-up timepoint, including discharge, 30 days, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months. Per protocol, all adverse events are required to be reported, regardless of relationship.
|
|
Nervous system disorders
Cerebellar Infarction
|
11.1%
1/9 • Number of events 1 • Through 30 days
Investigators are required to assess for adverse events at each follow-up timepoint, including discharge, 30 days, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months. Per protocol, all adverse events are required to be reported, regardless of relationship.
|
|
Nervous system disorders
Cerebrovascular Accident
|
22.2%
2/9 • Number of events 2 • Through 30 days
Investigators are required to assess for adverse events at each follow-up timepoint, including discharge, 30 days, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months. Per protocol, all adverse events are required to be reported, regardless of relationship.
|
|
Nervous system disorders
Hemianopia
|
11.1%
1/9 • Number of events 1 • Through 30 days
Investigators are required to assess for adverse events at each follow-up timepoint, including discharge, 30 days, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months. Per protocol, all adverse events are required to be reported, regardless of relationship.
|
|
Psychiatric disorders
Agitation
|
11.1%
1/9 • Number of events 1 • Through 30 days
Investigators are required to assess for adverse events at each follow-up timepoint, including discharge, 30 days, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months. Per protocol, all adverse events are required to be reported, regardless of relationship.
|
|
Psychiatric disorders
Confusional State
|
11.1%
1/9 • Number of events 1 • Through 30 days
Investigators are required to assess for adverse events at each follow-up timepoint, including discharge, 30 days, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months. Per protocol, all adverse events are required to be reported, regardless of relationship.
|
|
Psychiatric disorders
Paranoia
|
11.1%
1/9 • Number of events 1 • Through 30 days
Investigators are required to assess for adverse events at each follow-up timepoint, including discharge, 30 days, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months. Per protocol, all adverse events are required to be reported, regardless of relationship.
|
Other adverse events
| Measure |
Valiant Mona LSA Stent Graft System
n=9 participants at risk
TEVAR procedure using Medtronic Stent Graft \>
\> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
1/9 • Number of events 1 • Through 30 days
Investigators are required to assess for adverse events at each follow-up timepoint, including discharge, 30 days, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months. Per protocol, all adverse events are required to be reported, regardless of relationship.
|
|
Cardiac disorders
Bradycardia
|
11.1%
1/9 • Number of events 1 • Through 30 days
Investigators are required to assess for adverse events at each follow-up timepoint, including discharge, 30 days, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months. Per protocol, all adverse events are required to be reported, regardless of relationship.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
11.1%
1/9 • Number of events 1 • Through 30 days
Investigators are required to assess for adverse events at each follow-up timepoint, including discharge, 30 days, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months. Per protocol, all adverse events are required to be reported, regardless of relationship.
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 1 • Through 30 days
Investigators are required to assess for adverse events at each follow-up timepoint, including discharge, 30 days, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months. Per protocol, all adverse events are required to be reported, regardless of relationship.
|
|
Vascular disorders
Peripheral Ischaemia
|
11.1%
1/9 • Number of events 1 • Through 30 days
Investigators are required to assess for adverse events at each follow-up timepoint, including discharge, 30 days, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months. Per protocol, all adverse events are required to be reported, regardless of relationship.
|
Additional Information
Taryn Dellaripa, Principal Clinical Research Specialist
Medtronic Vascular
Phone: 541-301-3181
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place