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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01114724

Enrollment

Registered

2010-05-03

Start date

2010-05-31

Completion date

2017-10-31

Last updated

2021-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Dissection

Keywords

Thoracic dissection, Endovascular aortic repair

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.

Interventions

DEVICEValiant Thoracic Stent Graft with the Captivia Delivery System

All subjects will be implanted with this device

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
All Cause Mortality.	Up to 30 days after the stent graft implant.

Secondary

Measure	Time frame
Subjects With Successful Delivery and Deployment of the Device.	At implant.
Subjects With Coverage of Primary Tear	At implant
Aortic Rupture	Within 30 days
Subjects With Secondary Endovascular Procedures	Through12 months
All-cause Mortality	at 12 months
Aortic Remodeling: Subjects With Complete/Partial Thrombosis of the False Lumen Over the Stented Segment	At 12 months
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
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
Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events.	at 30 days
Aortic Remodeling: Subjects With Partial/Complete False Lumen Thrombosis Over the Stented Segment	At 6 months

Countries

United States

Participant flow

Participants by arm

Arm	Count
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	50
Total	50

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Death	8
Overall Study	Lost to Follow-up	1
Overall Study	Withdrawal by Subject	1

Baseline characteristics

Characteristic	Valiant Thoracic Stent Graft With the Captivia Delivery System
Age, Categorical <=18 years	1 Participants
Age, Categorical >=65 years	12 Participants
Age, Categorical Between 18 and 65 years	37 Participants
Age, Continuous	57.2 years STANDARD_DEVIATION 12.9
Region of Enrollment United States	50 participants
Sex: Female, Male Female	10 Participants
Sex: Female, Male Male	40 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 50
serious Total, serious adverse events	23 / 50

Outcome results

Primary

All Cause Mortality.

Time frame: Up to 30 days after the stent graft implant.

Population: Based on number of ITT subjects with available data

Arm	Measure	Value (NUMBER)
Valiant Thoracic Stent Graft With the Captivia Delivery System	All Cause Mortality.	4 participants

Secondary

All-cause Mortality

Time frame: 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)

Arm	Measure	Value (NUMBER)
Valiant Thoracic Stent Graft With the Captivia Delivery System	All-cause Mortality	7 participants

Secondary