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

• Sponsor: Medtronic Cardiovascular (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01114724
• Collaborator: Medtronic (Industry)
• Enrollment: 50
• Locations: 17
• Arm: 1
• Duration (Months): 89
• Patients Per Site: 2.9
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if the Valiant stent graft is safe and effective in treating patients who have a thoracic dissection. A thoracic dissection is a tear in the wall of the aorta, that causes blood to flow between the layers of the aorta and force the layers apart (dissect). This condition is a medical emergency and can quickly lead to death. Since stent grafting has been an effective way to treat other aortic conditions such as aneurysms (bulge in aorta wall), it is believed that the device would be effective in treating dissections. Information will be collected on the performance of the device for 5 years.

Condition or Disease	Intervention/Treatment	Phase
Aortic Dissection	Device: Valiant Thoracic Stent Graft with the Captivia Delivery System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Valiant® Thoracic Stent Graft With the Captivia Delivery System. Evaluation of 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
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Valiant Thoracic Stent Graft with the Captivia Delivery System	Device: Valiant Thoracic Stent Graft with the Captivia Delivery System; All subjects will be implanted with this device

Outcome Measures

Primary Outcome Measures

1. All Cause Mortality. [Up to 30 days after the stent graft implant.]

Secondary Outcome Measures

1. All-cause Mortality [at 12 months]

2. Subjects With Successful Delivery and Deployment of the Device. [At implant.]

3. Subjects With Coverage of Primary Tear [At implant]

4. Aortic Rupture [Within 30 days]

5. Aortic Rupture [Within 12 months]

6. Subjects With Secondary Endovascular Procedures [Through12 months]

7. Aortic Remodeling: Subjects With Partial/Complete False Lumen Thrombosis Over the Stented Segment [At 6 months]

8. Aortic Remodeling: Subjects With Complete/Partial Thrombosis of the False Lumen Over the Stented Segment [At 12 months]

9. Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft [at 6 months]

10. Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft [at 12 months]

11. Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft [at 6 months]

12. Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft [at 12 months]

13. Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events. [at 30 days]

14. Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events. [at 12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria

• Subject signed an informed consent.

• Subject is at least 18 years old.

• Subject has an acute, complicated Type B aortic dissection with evidence of at least one of the following:

• Malperfusion (visceral, renal, spinal cord and/or lower limb ischemia)

• Visceral ischemia measured by either radiographic or clinical evidence.

• Renal ischemia measured by either radiographic or clinical evidence.

• Spinal cord ischemia measured by either radiographic or clinical evidence.

• Lower limb ischemia measured by either radiographic or clinical evidence.

• Rupture - Measured by radiographic or clinical evidence.

• Subject is hemodynamically stable.

• Subject's anatomy must meet all of the following anatomical criteria:

Proximal landing zone aortic diameter must be between 20 mm and 44 mm;

• Centerline distance from distal margin of left CCA or in cases of bovine anatomy, innominate artery, to start of most proximal tear must be ≥ 20 mm;

• Subject has patent iliac or femoral arteries or can tolerate an iliac conduit that allows endovascular access to the dissection site with the delivery system of the appropriate sized device.

• Thoracic aortic dissection is confirmed, at a minimum, by diagnostic contrast-enhanced computerized tomography angiogram (CTA) with 3-D reconstruction, and/or contrast enhanced magnetic resonance angiogram (MRA) obtained prior to the implant procedure.

Exclusion Criteria

• Planned placement of the COVERED portion of the stent graft over the left carotid artery, or the celiac trunk.

• Subject has systemic infection.

• Subject is pregnant.

• Subject has received a previous stent or stent graft or previous surgical repair in the DTA.

• Subject has had a cerebral vascular accident (CVA) within 2 months.

• Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.

• Subject has a history of Marfan Syndrome or other connective tissue disorder.

• Subject is currently participating in an investigational drug or device clinical trial which would interfere with the endpoints and follow-ups of this study.

• Subject has a known allergy or intolerance to the device components.

• Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.

• Subject has a co-morbidity causing expected survival to be less than 1 year.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	USC Keck School of Medicine	Los Angeles	California	United States	90033
2	Cedars Sinai Medical Center	Los Angeles	California	United States	90048
3	Harbor UCLA	Torrance	California	United States	90502
4	Washington Hospital D.C.	Washington	District of Columbia	United States	20010
5	University of Florida	Gainesville	Florida	United States	32610
6	Northwestern Memorial	Chicago	Illinois	United States	60601
7	University of Michigan	Ann Arbor	Michigan	United States	48109
8	New York Presbyterian Weill Cornell	New York	New York	United States	10065
9	Novant Health Heart and Vascular Institute	Charlotte	North Carolina	United States	28204
10	Duke University Medical Center	Durham	North Carolina	United States	27710
11	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
12	Vanderbilt Medical Center	Nashville	Tennessee	United States	37232
13	Heart Hospital Medical Center	Dallas	Texas	United States	75230
14	Baylor	Houston	Texas	United States	77030
15	Memorial Hermann Heart and Vascular Institute	Houston	Texas	United States	77030
16	St. Luke's Episcopal Hospital	Houston	Texas	United States	77030
17	Virginia Commonwealth University MCV Richmond	Richmond	Virginia	United States	23298

Sponsors and Collaborators

• Medtronic Cardiovascular
• Medtronic

Investigators

• Principal Investigator: Joseph E. Bavaria, M.D., Univ. of Pennsylvania Health System
• Principal Investigator: W. Anthony Lee, M.D., F.A.C.S, Lynn Heart Institute, Boca Raton Community Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Cardiovascular
• ClinicalTrials.gov Identifier: NCT01114724
• Other Study ID Numbers: IP # 118
• First Posted: May 3, 2010
• Last Update Posted: Oct 29, 2021
• Last Verified: Oct 1, 2021

• Keywords provided by Medtronic Cardiovascular: Thoracic dissection; Endovascular aortic repair
• Additional relevant MeSH terms: Aneurysm, Dissecting

Study Results

Participant Flow

Arm/Group Title	Valiant Thoracic Stent Graft With the Captivia Delivery System
Arm/Group Description	Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
Period Title: Overall Study
STARTED	50
COMPLETED	40
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	Valiant Thoracic Stent Graft With the Captivia Delivery System
Arm/Group Description	Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
Overall Participants	50
Age (Count of Participants)
<=18 years	1 2%
Between 18 and 65 years	37 74%
>=65 years	12 24%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.2 (12.9)
Sex: Female, Male (Count of Participants)
Female	10 20%
Male	40 80%
Region of Enrollment (participants) [Number]
United States	50 100%

Outcome Measures

1. Primary Outcome

Title	All Cause Mortality.
Time Frame	Up to 30 days after the stent graft implant.

Outcome Measure Data

Analysis Population Description

Based on number of ITT subjects with available data

Arm/Group Title	Valiant Thoracic Stent Graft With the Captivia Delivery System
Arm/Group Description	Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
Measure Participants	50
Number [participants]	4 8%

2. Secondary Outcome

Title	All-cause Mortality
Time Frame	at 12 months

Outcome Measure Data

Analysis Population Description

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)

Arm/Group Title	Valiant Thoracic Stent Graft With the Captivia Delivery System
Arm/Group Description	Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
Measure Participants	48
Number [participants]	7 14%

3. Secondary Outcome

Title	Subjects With Successful Delivery and Deployment of the Device.
Time Frame	At implant.

Outcome Measure Data

Analysis Population Description

Based on number of ITT subjects with available data

Arm/Group Title	Valiant Thoracic Stent Graft With the Captivia Delivery System
Arm/Group Description	Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
Measure Participants	50
Number [participants]	50 100%

4. Secondary Outcome

Title	Subjects With Coverage of Primary Tear
Time Frame	At implant

Outcome Measure Data

Analysis Population Description

Based on number of ITT subjects with available data

Arm/Group Title	Valiant Thoracic Stent Graft With the Captivia Delivery System
Arm/Group Description	Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
Measure Participants	50
Number [participants]	50 100%

5. Secondary Outcome

Title	Aortic Rupture
Time Frame	Within 30 days

Outcome Measure Data

Analysis Population Description

Based on number of ITT subjects with available data.

Arm/Group Title	Valiant Thoracic Stent Graft With the Captivia Delivery System
Arm/Group Description	Valiant Thoracic Stent Graft will the Captivia Delivery System: All subjects will be implanted with this device
Measure Participants	50
Number [participants]	0 0%

6. Secondary Outcome

Title	Aortic Rupture
Time Frame	Within 12 months

Outcome Measure Data

Analysis Population Description

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)

Arm/Group Title	Valiant Thoracic Stent Graft With the Captivia Delivery System
Arm/Group Description	Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
Measure Participants	48
Number [participants]	0 0%

7. Secondary Outcome

Title	Subjects With Secondary Endovascular Procedures
Time Frame	Through12 months

Outcome Measure Data

Analysis Population Description

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)

Arm/Group Title	Valiant Thoracic Stent Graft With the Captivia Delivery System
Arm/Group Description	Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
Measure Participants	48
Number [participants]	4 8%

8. Secondary Outcome

Title	Aortic Remodeling: Subjects With Partial/Complete False Lumen Thrombosis Over the Stented Segment
Time Frame	At 6 months

Outcome Measure Data

Analysis Population Description

Based on number of ITT subjects with evaluable imaging data.

Arm/Group Title	Valiant Thoracic Stent Graft With the Captivia Delivery System
Arm/Group Description	Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
Measure Participants	33
Number [participants]	25 50%

9. Secondary Outcome

Title	Aortic Remodeling: Subjects With Complete/Partial Thrombosis of the False Lumen Over the Stented Segment
Time Frame	At 12 months

Outcome Measure Data

Analysis Population Description

Based on number of ITT subjects with evaluable imaging data.

Arm/Group Title	Valiant Thoracic Stent Graft With the Captivia Delivery System
Arm/Group Description	Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
Measure Participants	34
Number [participants]	27 54%

10. Secondary Outcome

Title	Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft
Time Frame	at 6 months

Outcome Measure Data

Analysis Population Description

Based on number of ITT subjects with evaluable imaging data.

Arm/Group Title	Valiant Thoracic Stent Graft With the Captivia Delivery System
Arm/Group Description	Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
Measure Participants	33
Number [participants]	31 62%

11. Secondary Outcome

Title	Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft
Time Frame	at 12 months

Outcome Measure Data

Analysis Population Description

Based on number of ITT subjects with evaluable imaging data.

Arm/Group Title	Valiant Thoracic Stent Graft With the Captivia Delivery System
Arm/Group Description	Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
Measure Participants	34
Number [participants]	32 64%

12. Secondary Outcome

Title	Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft
Time Frame	at 6 months

Outcome Measure Data

Analysis Population Description

Based on number of ITT subjects with evaluable imaging data.

Arm/Group Title	Valiant Thoracic Stent Graft With the Captivia Delivery System
Arm/Group Description	Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
Measure Participants	33
Number [participants]	25 50%

13. Secondary Outcome

Title	Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft
Time Frame	at 12 months

Outcome Measure Data

Analysis Population Description

Based on number of ITT subjects with evaluable imaging data.

Arm/Group Title	Valiant Thoracic Stent Graft With the Captivia Delivery System
Arm/Group Description	Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
Measure Participants	34
Number [participants]	28 56%

14. Secondary Outcome

Title	Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events.
Time Frame	at 30 days

Outcome Measure Data

Analysis Population Description

Based on number of ITT subjects with available data.

Arm/Group Title	Valiant Thoracic Stent Graft With the Captivia Delivery System
Arm/Group Description	Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
Measure Participants	50
Number [participants]	19 38%

15. Secondary Outcome

Title	Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events.
Time Frame	at 12 months

Outcome Measure Data

Analysis Population Description

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,

Arm/Group Title	Valiant Thoracic Stent Graft With the Captivia Delivery System
Arm/Group Description	Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
Measure Participants	49
Number [participants]	23 46%

Adverse Events

Time Frame	12 months
Arm/Group Title	1. Dissection
Arm/Group Description	Medtronic Dissection
All Cause Mortality
	1. Dissection
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	1. Dissection
	Affected / at Risk (%)	# Events
Total	23/50 (46%)
Cardiac disorders
Cardiac Arrest	2/50 (4%)	2
Cardiac Tamponade	1/50 (2%)	1
Gastrointestinal disorders
Ileus	1/50 (2%)	1
Intestinal Ischaemia	1/50 (2%)	1
General disorders
Continued Perfusion from a Branch Vessel requiring Treatment	1/50 (2%)	1
Infections and infestations
Pneumonia	2/50 (4%)	2
Sepsis	1/50 (2%)	1
Injury, poisoning and procedural complications
Incision Site Pain	1/50 (2%)	1
Nerve Injury	1/50 (2%)	1
Stent-Graft Endoleak	2/50 (4%)	2
Wound	1/50 (2%)	1
Investigations
White Blood Cell Count Increased	1/50 (2%)	1
Musculoskeletal and connective tissue disorders
Muscular Weakness	1/50 (2%)	1
Rhabdomyolysis	1/50 (2%)	1
Nervous system disorders
Cerebral Ischaemia	1/50 (2%)	1
Cerebrovascular Accident	3/50 (6%)	3
Monoplegia	1/50 (2%)	1
Paralysis	1/50 (2%)	1
Spinal Cord Ischaemia	1/50 (2%)	1
Paraplegia	1/50 (2%)	1
Renal and urinary disorders
Renal Failure Acute	4/50 (8%)	4
Respiratory, thoracic and mediastinal disorders
Haemothorax	1/50 (2%)	1
Pulmonary Embolism	1/50 (2%)	1
Vascular disorders
Aortic Aneurysm	2/50 (4%)	2
Aortic Dissection	2/50 (4%)	2
Deep Vein Thrombosis	1/50 (2%)	1
Haemorrhage	1/50 (2%)	1
Hypertension	1/50 (2%)	1
Intermittent Claudication	1/50 (2%)	1
Peripheral Vascular Disorder	1/50 (2%)	1
Subclavian Artery Embolism	1/50 (2%)	1
Other (Not Including Serious) Adverse Events
	1. Dissection
	Affected / at Risk (%)	# Events
Total	0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.