Trial Outcomes & Findings for Study to Evaluate the Clinical Performance of the Valiant Thoracic Stent Graft With the Captivia Delivery System (Valiant Captivia) for the Treatment of Acute, Complicated Type B Aortic Dissections (NCT NCT01114724)

NCT ID: NCT01114724

Last Updated: 2021-10-29

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: Up to 30 days after the stent graft implant.
• Results posted on: 2021-10-29

Participant Flow

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	40
Overall Study NOT COMPLETED	10

Reasons for withdrawal

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 Death	8
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Study to Evaluate the Clinical Performance of the Valiant Thoracic Stent Graft With the Captivia Delivery System (Valiant Captivia) for the Treatment of Acute, Complicated Type B Aortic Dissections

Baseline characteristics by cohort

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
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Age, Continuous	57.2 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 30 days after the stent graft implant.

Population: Based on number of ITT subjects with available data

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.	4 participants

SECONDARY outcome

Timeframe: at 12 months

Population: Based on number of ITT subjects with available data. Subjects were considered unevaluable if they were withdrawn before the lower limit of the 12 months follow-up window or were lost to follow-up before the lower limit of the 12 months follow-up window. (One patient withdrew and one was lost to follow-up)

Outcome measures

Measure	Valiant Thoracic Stent Graft With the Captivia Delivery System n=48 Participants Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
All-cause Mortality	7 participants

SECONDARY outcome

Timeframe: At implant.

Population: Based on number of ITT subjects with available data

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
Subjects With Successful Delivery and Deployment of the Device.	50 participants

SECONDARY outcome

Timeframe: At implant

Population: Based on number of ITT subjects with available data

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
Subjects With Coverage of Primary Tear	50 participants

SECONDARY outcome

Timeframe: Within 30 days

Population: Based on number of ITT subjects with available data.

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
Aortic Rupture	0 participants

SECONDARY outcome

Timeframe: Within 12 months

Population: Based on number of ITT subjects with available data. Subjects were considered unevaluable if they were withdrawn before the lower limit of the 12 months follow-up window or were lost to follow-up before the lower limit of the 12 months follow-up window. (One patient withdrew and one was lost to follow-up)

Outcome measures

Measure	Valiant Thoracic Stent Graft With the Captivia Delivery System n=48 Participants Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
Aortic Rupture	0 participants

SECONDARY outcome

Timeframe: Through12 months

Population: Based on number of ITT subjects with available data. Subjects were considered unevaluable if they were withdrawn before the lower limit of the 12 months follow-up window or were lost to follow-up before the lower limit of the 12 months follow-up window. (One patient withdrew and one was lost to follow-up)

Outcome measures

Measure	Valiant Thoracic Stent Graft With the Captivia Delivery System n=48 Participants Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
Subjects With Secondary Endovascular Procedures	4 participants

SECONDARY outcome

Timeframe: At 6 months

Population: Based on number of ITT subjects with evaluable imaging data.

Outcome measures

Measure	Valiant Thoracic Stent Graft With the Captivia Delivery System n=33 Participants Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
Aortic Remodeling: Subjects With Partial/Complete False Lumen Thrombosis Over the Stented Segment	25 participants

SECONDARY outcome

Timeframe: At 12 months

Population: Based on number of ITT subjects with evaluable imaging data.

Outcome measures

Measure	Valiant Thoracic Stent Graft With the Captivia Delivery System n=34 Participants Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
Aortic Remodeling: Subjects With Complete/Partial Thrombosis of the False Lumen Over the Stented Segment	27 participants

SECONDARY outcome

Timeframe: at 6 months

Population: Based on number of ITT subjects with evaluable imaging data.

Outcome measures

Measure	Valiant Thoracic Stent Graft With the Captivia Delivery System n=33 Participants Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft	31 participants

SECONDARY outcome

Timeframe: at 12 months

Population: Based on number of ITT subjects with evaluable imaging data.

Outcome measures

Measure	Valiant Thoracic Stent Graft With the Captivia Delivery System n=34 Participants Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft	32 participants

SECONDARY outcome

Timeframe: at 6 months

Population: Based on number of ITT subjects with evaluable imaging data.

Outcome measures

Measure	Valiant Thoracic Stent Graft With the Captivia Delivery System n=33 Participants Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft	25 participants

SECONDARY outcome

Timeframe: at 12 months

Population: Based on number of ITT subjects with evaluable imaging data.

Outcome measures

Measure	Valiant Thoracic Stent Graft With the Captivia Delivery System n=34 Participants Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft	28 participants

SECONDARY outcome

Timeframe: at 30 days

Population: Based on number of ITT subjects with available data.

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
Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events.	19 participants

SECONDARY outcome

Timeframe: at 12 months

Population: Based on number of ITT subjects with available data. Subjects were considered unevaluable if they were withdrawn or were lost to follow-up before the lower limit of the 12 mos follow-up window.One subject was lost to follow-up and one withdrew before 12 mos. One of these subjects experienced an AE before study exit and was included in the analysis,

Outcome measures

Measure	Valiant Thoracic Stent Graft With the Captivia Delivery System n=49 Participants Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events.	23 participants

Adverse Events

1. Dissection

Serious events: 23 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	1. Dissection n=50 participants at risk Medtronic Dissection
Cardiac disorders Cardiac Arrest	4.0% 2/50 • Number of events 2 • 12 months
Cardiac disorders Cardiac Tamponade	2.0% 1/50 • Number of events 1 • 12 months
Gastrointestinal disorders Ileus	2.0% 1/50 • Number of events 1 • 12 months
Gastrointestinal disorders Intestinal Ischaemia	2.0% 1/50 • Number of events 1 • 12 months
General disorders Continued Perfusion from a Branch Vessel requiring Treatment	2.0% 1/50 • Number of events 1 • 12 months
Infections and infestations Pneumonia	4.0% 2/50 • Number of events 2 • 12 months
Infections and infestations Sepsis	2.0% 1/50 • Number of events 1 • 12 months
Injury, poisoning and procedural complications Incision Site Pain	2.0% 1/50 • Number of events 1 • 12 months
Injury, poisoning and procedural complications Nerve Injury	2.0% 1/50 • Number of events 1 • 12 months
Injury, poisoning and procedural complications Stent-Graft Endoleak	4.0% 2/50 • Number of events 2 • 12 months
Injury, poisoning and procedural complications Wound	2.0% 1/50 • Number of events 1 • 12 months
Investigations White Blood Cell Count Increased	2.0% 1/50 • Number of events 1 • 12 months
Musculoskeletal and connective tissue disorders Muscular Weakness	2.0% 1/50 • Number of events 1 • 12 months
Musculoskeletal and connective tissue disorders Rhabdomyolysis	2.0% 1/50 • Number of events 1 • 12 months
Nervous system disorders Cerebral Ischaemia	2.0% 1/50 • Number of events 1 • 12 months
Nervous system disorders Cerebrovascular Accident	6.0% 3/50 • Number of events 3 • 12 months
Nervous system disorders Monoplegia	2.0% 1/50 • Number of events 1 • 12 months
Nervous system disorders Paralysis	2.0% 1/50 • Number of events 1 • 12 months
Nervous system disorders Spinal Cord Ischaemia	2.0% 1/50 • Number of events 1 • 12 months
Renal and urinary disorders Renal Failure Acute	8.0% 4/50 • Number of events 4 • 12 months
Respiratory, thoracic and mediastinal disorders Haemothorax	2.0% 1/50 • Number of events 1 • 12 months
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	2.0% 1/50 • Number of events 1 • 12 months
Vascular disorders Aortic Aneurysm	4.0% 2/50 • Number of events 2 • 12 months
Vascular disorders Aortic Dissection	4.0% 2/50 • Number of events 2 • 12 months
Vascular disorders Deep Vein Thrombosis	2.0% 1/50 • Number of events 1 • 12 months
Vascular disorders Haemorrhage	2.0% 1/50 • Number of events 1 • 12 months
Vascular disorders Hypertension	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 Vascular Disorder	2.0% 1/50 • Number of events 1 • 12 months
Vascular disorders Subclavian Artery Embolism	2.0% 1/50 • Number of events 1 • 12 months
Nervous system disorders Paraplegia	2.0% 1/50 • Number of events 1 • 12 months

Other adverse events

Adverse event data not reported

Additional Information

Celeste Claudy - Study Lead

Medtronic Inc., Aortic and Peripheral Vascular

Phone: 763-514-0130

Email: celeste.m.claudy@medtronic.com

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