Aortic DissectionNCT01114724
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
A study testing Valiant Thoracic Stent Graft with the Captivia Delivery System in people with Aortic Dissection, run by Medtronic Cardiovascular at 17 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Dissection
- What is being tested?
- Valiant Thoracic Stent Graft with the Captivia Delivery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 17 sitesUnited States
- Study dates
- May 2010to Oct 2017
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
University of Michigan
Ann Arbor, Michigan, 48109
Novant Health Heart and Vascular Institute
Charlotte, North Carolina, 28204
Northwestern Memorial
Chicago, Illinois, 60601
Heart Hospital Medical Center
Dallas, Texas, 75230
Duke University Medical Center
Durham, North Carolina, 27710
University of Florida
Gainesville, Florida, 32610
Baylor
Houston, Texas, 77030
Memorial Hermann Heart and Vascular Institute
Houston, Texas, 77030
St. Luke's Episcopal Hospital
Houston, Texas, 77030
USC Keck School of Medicine
Los Angeles, California, 90033
Cedars Sinai Medical Center
Los Angeles, California, 90048
Vanderbilt Medical Center
Nashville, Tennessee, 37232
New York Presbyterian Weill Cornell
New York, New York, 10065
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Virginia Commonwealth University MCV Richmond
Richmond, Virginia, 23298
Harbor UCLA
Torrance, California, 90502
Washington Hospital D.C.
Washington D.C., District of Columbia, 20010
About this study
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
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.
- Conditions
- Aortic Dissection
- Being tested
- Valiant Thoracic Stent Graft with the Captivia Delivery System
- Keywords
- Thoracic dissection, Endovascular aortic repair
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valiant Thoracic Stent Graft with the Captivia Delivery SystemDevice
All subjects will be implanted with this device
| Study group | Role | What they receive |
|---|---|---|
| Valiant Thoracic Stent Graft with the Captivia Delivery System | Experimental | Not described Receives: Device: Valiant Thoracic Stent Graft with the Captivia Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
All Cause Mortality.
Measured: Up to 30 days after the stent graft implant.
Secondary outcomes (14)
All-cause Mortality
Measured: at 12 months
Subjects With Successful Delivery and Deployment of the Device.
Measured: At implant.
Subjects With Coverage of Primary Tear
Measured: At implant
Aortic Rupture
Measured: Within 30 days
Aortic Rupture
Measured: Within 12 months
Subjects With Secondary Endovascular Procedures
Measured: Through12 months
Aortic Remodeling: Subjects With Partial/Complete False Lumen Thrombosis Over the Stented Segment
Measured: At 6 months
Aortic Remodeling: Subjects With Complete/Partial Thrombosis of the False Lumen Over the Stented Segment
Measured: 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
Measured: at 6 months
Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft
Measured: at 12 months
Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft
Measured: 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
Measured: at 12 months
Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events.
Measured: at 30 days
Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events.
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2013
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Joseph E. Bavaria, M.D., Principal investigator, Univ. of Pennsylvania Health SystemW. Anthony Lee, M.D., F.A.C.S, Principal investigator, Lynn Heart Institute, Boca Raton Community Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01114724
- Sponsor's protocol ID
- IP # 118
- Status last verified
- Oct 2021
- First submitted
- 26 Apr 2010
- Last updated
- 29 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 32654872