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
1 other identifier
interventional
50
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2010
Longer than P75 for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedFirst Posted
Study publicly available on registry
May 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedResults Posted
Study results publicly available
July 3, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedOctober 29, 2021
October 1, 2021
3 years
April 26, 2010
May 30, 2014
October 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All Cause Mortality.
Up to 30 days after the stent graft implant.
Secondary Outcomes (14)
All-cause Mortality
at 12 months
Subjects With Successful Delivery and Deployment of the Device.
At implant.
Subjects With Coverage of Primary Tear
At implant
Aortic Rupture
Within 30 days
Aortic Rupture
Within 12 months
- +9 more secondary outcomes
Study Arms (1)
Valiant Thoracic Stent Graft with the Captivia Delivery System
EXPERIMENTALInterventions
All subjects will be implanted with this device
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic Cardiovascularlead
- Medtroniccollaborator
Study Sites (17)
USC Keck School of Medicine
Los Angeles, California, 90033, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Harbor UCLA
Torrance, California, 90502, United States
Washington Hospital D.C.
Washington D.C., District of Columbia, 20010, United States
University of Florida
Gainesville, Florida, 32610, United States
Northwestern Memorial
Chicago, Illinois, 60601, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
New York Presbyterian Weill Cornell
New York, New York, 10065, United States
Novant Health Heart and Vascular Institute
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Vanderbilt Medical Center
Nashville, Tennessee, 37232, United States
Heart Hospital Medical Center
Dallas, Texas, 75230, United States
Baylor
Houston, Texas, 77030, United States
Memorial Hermann Heart and Vascular Institute
Houston, Texas, 77030, United States
St. Luke's Episcopal Hospital
Houston, Texas, 77030, United States
Virginia Commonwealth University MCV Richmond
Richmond, Virginia, 23298, United States
Related Publications (1)
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.
PMID: 32654872DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Celeste Claudy - Study Lead
- Organization
- Medtronic Inc., Aortic and Peripheral Vascular
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2010
First Posted
May 3, 2010
Study Start
May 1, 2010
Primary Completion
May 1, 2013
Study Completion
October 1, 2017
Last Updated
October 29, 2021
Results First Posted
July 3, 2014
Record last verified: 2021-10