Clinical trial NCT01114724: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Dissection
Keywords: Thoracic dissection
Endovascular aortic repair
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2010-05-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: All Cause Mortality.
timeFrame: Up to 30 days after the stent graft implant.
Secondary outcomes:
measure: All-cause Mortality
timeFrame: at 12 months
measure: Subjects With Successful Delivery and Deployment of the Device.
timeFrame: At implant.
measure: Subjects With Coverage of Primary Tear
timeFrame: At implant
measure: Aortic Rupture
timeFrame: Within 30 days
measure: Aortic Rupture
timeFrame: Within 12 months
measure: Subjects With Secondary Endovascular Procedures
timeFrame: Through12 months
measure: Aortic Remodeling: Subjects With Partial/Complete False Lumen Thrombosis Over the Stented Segment
timeFrame: At 6 months
measure: Aortic Remodeling: Subjects With Complete/Partial Thrombosis of the False Lumen Over the Stented Segment
timeFrame: At 12 months
measure: Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft
timeFrame: at 6 months
measure: Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft
timeFrame: at 12 months
measure: Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft
timeFrame: at 6 months
measure: Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft
timeFrame: at 12 months
measure: Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events.
timeFrame: at 30 days
measure: Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events.
timeFrame: at 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Keck School of Medicine
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Torrance
country: United States
facility: Harbor UCLA
state: California
city: Washington
country: United States
facility: Washington Hospital D.C.
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Chicago
country: United States
facility: Northwestern Memorial
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: New York
country: United States
facility: New York Presbyterian Weill Cornell
state: New York
city: Charlotte
country: United States
facility: Novant Health Heart and Vascular Institute
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Heart Hospital Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Heart and Vascular Institute
state: Texas
city: Houston
country: United States
facility: St. Luke's Episcopal Hospital
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University MCV Richmond
state: Virginia
Study officials:
affiliation: Univ. of Pennsylvania Health System
name: Joseph E. Bavaria, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Lynn Heart Institute, Boca Raton Community Hospital
name: W. Anthony Lee, M.D., F.A.C.S
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bavaria JE, Brinkman WT, Hughes GC, Shah AS, Charlton-Ouw KM, Azizzadeh A, White RA. Five-year outcomes of endovascular repair of complicated acute type B aortic dissections. J Thorac Cardiovasc Surg. 2022 Feb;163(2):539-548.e2. doi: 10.1016/j.jtcvs.2020.03.162. Epub 2020 May 13.