Aortic Aneurysm, ThoracicVEVONCT02652949
Valiant Evo US Clinical Trial
A study testing Valiant Evo Thoracic Stent Graft System in people with Aortic Aneurysm, Thoracic, run by Medtronic Cardiovascular at 21 sites in United States.
Trial summary
The purpose of the Valiant Evo US Clinical Trial is to demonstrate the safety and effectiveness of the Valiant Evo Thoracic Stent Graft System in subjects with a descending thoracic aortic aneurysm (DTAA) who are candidates for endovascular repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Thoracic
- What is being tested?
- Valiant Evo Thoracic Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 21 sitesUnited States
- Study dates
- Apr 2016to 2 Mar 2023
- 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 is ≥18 years old.
- Subject understands and voluntarily has signed and dated the Informed Consent Form approved by the Sponsor and by the Ethics Committee for this study.
- Subject presents a Descending Thoracic Aortic Aneurysm (DTAA) which is localized below the ostium of Left Subclavian Artery (LSA) and above the ostium of celiac trunk
- Subject has a DTAA that is one of the following:
- A fusiform aneurysm with a maximum diameter that:
- is ≥ 50 mm and/or:
Show all 14Show fewer
- is > 2 times the diameter of the non-aneurysmal thoracic aorta and/or:
- is < 50 mm and has grown ≥ 5 mm within previous 12 months
- A saccular aneurysm or a penetrating atherosclerotic ulcer
- Subject's anatomy must meet all of the following anatomical criteria as demonstrated on contrast-enhanced CT and/or on contrast-enhanced Magnetic Resonance Angiogram (MRA) obtained within four (4) months prior to implant procedure:
- Proximal and distal non-aneurysmal aortic neck diameter measurements must be ≥ 16 mm and ≤ 42 mm;
- Proximal non-aneurysmal aortic neck length must be ≥ 20 mm (for FreeFlo configuration) and ≥ 25 mm (for Closed Web configuration) distal to the left common carotid artery (LCCA). Note: Proximal aortic neck length may include covering the LSA (with or without discretionary revascularization) when necessary to optimize device fixation and maximize aortic neck length. If occlusion of the LSA ostium is required to obtain adequate neck length for fixation and sealing, transposition or bypass to the LSA may be warranted.
- Distal non-aneurysmal aortic neck length must be ≥ 20 mm
- Subject has adequate arterial access site or can tolerate a conduit that allows endovascular access to the aneurysmal site with the delivery system of the appropriate sized device chosen for the treatment.
Who cannot join
- Subject has a life expectancy of less than 1 year
- Subject is participating in another investigational drug or device study which would interfere with the endpoints and follow-ups of this study.
- Subject is pregnant.
- Subject requires planned placement of the covered proximal end of the stent graft to occur in zones 0 or 1.
- Subject has a thoracic aneurysm with a contained rupture or localized at the anastomosis of a previous graft (pseudo-/false aneurysm).
- Subject has a mycotic aneurysm.
Show all 22Show fewer
- Subject has a dissection (type A or B) or an intramural hematoma or an aortic rupture in addition to the thoracic aneurysm.
- Subject requires emergent aneurysm treatment, e.g., trauma or rupture.
- Subject has received a previous stent or stent graft or previous surgical repair in the ascending and/or descending thoracic aorta, and/or in the aortic arch.
- Subject requires surgical or endovascular treatment of an infra-renal aneurysm at the time of implant
- Subject has had previous surgical or endovascular treatment of an infra-renal aortic aneurysm.
- Treatment with the Valiant Evo Thoracic Stent Graft would require intentional revascularization of the brachio-cephalic artery or the left common carotid artery or the celiac trunk.
- Subject has had or plans to have a major surgical or interventional procedure within 30 days before or 30 days after the planned implantation of the Valiant Evo Thoracic Stent Graft. This does not include planned procedures that are needed for the safe and effective placement of the stent graft (i.e., carotid/subclavian transposition, carotid/subclavian bypass procedure).
- Subject has a significant and/or circumferential aortic mural thrombus at either the proximal or distal attachment sites that could compromise fixation and seal of the implanted stent graft.
- Subject has a connective tissue disease (e.g., Marfan's syndrome, aortic medial degeneration).
- Subject has a bleeding diathesis or coagulopathy, or refuses blood transfusion.
- Subject has had a Myocardial Infarction (MI) within 3 months of the procedure.
- Subject has had a Cerebrovascular Accident (CVA) within 3 months of the procedure.
- Subject has a known allergy or intolerance to the device materials
- Subject has a known allergy to anesthetic drugs
- Subject has a known hypersensitivity or contraindication to anticoagulants, or contrast media, which is not amenable to pretreatment.
- Subject has active or systemic infection at the time of the index procedure.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Albany Medical Center
Albany, New York, 12208
University of Michigan Health System
Ann Arbor, Michigan, 48109
Emory University Hospital
Atlanta, Georgia, 30322
University of North Carolina
Chapel Hill, North Carolina, 27514
Carolinas Medical Center
Charlotte, North Carolina, 28203
University of Virginia Medical Center
Charlottesville, Virginia, 22908
Cleveland Clinic
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43210
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, 43214
Duke University Medical Center
Durham, North Carolina, 27710
Inova Fairfax Hospital
Falls Church, Virginia, 22042
University of Florida
Gainesville, Florida, 32610
Memorial Hermann Texas Medical Center
Houston, Texas, 77030
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Abrazo Arizona Heart Institute
Phoenix, Arizona, 85006
The Heart Hospital Baylor Plano
Plano, Texas, 75093
Barnes Jewish Hospital
St Louis, Missouri, 63110
Stanford Hospital
Stanford, California, 94305
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
The purpose of the Valiant Evo US Clinical Trial is to demonstrate the safety and effectiveness of the Valiant Evo Thoracic Stent Graft System in subjects with a descending thoracic aortic aneurysm (DTAA) who are candidates for endovascular repair.
Read the detailed description
Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 total subjects, in order to obtain 87 evaluable subjects for the primary endpoint. The two protocols are identical, and the trials were run simultaneously to enroll subjects concurrently in the United States (US) and Outside United States (OUS). The poolability on the primary endpoint between US and OUS data will be assessed using Fisher's exact test during the data analysis. Data for both trials will be combined and presented as a pooled analysis.
- Conditions
- Aortic Aneurysm, Thoracic
- Being tested
- Valiant Evo Thoracic Stent Graft System
- Medical subject headings
- Aortic Aneurysm, Thoracic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valiant Evo Thoracic Stent Graft SystemDevice
Procedure: thoracic endovascular aneurysm repair (TEVAR)
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Repair | Experimental | Valiant Evo Thoracic Stent Graft System Receives: Device: Valiant Evo Thoracic Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Safety and Effectiveness Endpoint That is Based on the Percentage of Subjects Who Experienced (a) Access and/or Deployment Failures; and/or (b) Major Device Effect (MDE) Within 30 Days Post Index Procedure
MDEs include: device-related secondary procedures, device-related mortality, conversion to open surgery, thoracic aortic aneurysm rupture.
Access failure: Inability to insert device due to mechanical failure or anatomic exclusions of the femoral or iliac arteries.
Deployment failure: Deployment failure due to subject anatomy or mechanical failure. Specifically, deployment of the stent graft from the delivery system.
Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the primary endpoint global cohort of 87 subjects. The poolability on the primary endpoint between US and OUS data were assessed using Fisher's exact test.
Measured: 30 Days
Secondary outcomes (7)
Safety and Effectiveness Outcome
Safety and Effectiveness outcome measures between 0-30 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US [OUS]).
Measures include: peri-operative mortality, adverse events (AE), major adverse events (MAE), serious adverse events (SAE), secondary procedures, loss of stent graft patency, and endoleaks.
Measured: 30 Days
Safety and Effectiveness Outcome
Safety outcome measures between 0-183 days and Effectiveness outcome measures between 31-183 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.
Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
Measured: 6 month
Safety and Effectiveness Outcome
Safety outcome measures between 0-365 days and Effectiveness outcome measures between 184-365 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.
Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
Measured: 12 Month
Safety and Effectiveness Outcome
Safety outcome measures between 0-730 days and Effectiveness outcome measures between 366-730 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.
Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
Measured: 24 Month
Safety and Effectiveness Outcome
Safety outcome measures between 0-1095 days and Effectiveness outcome measures between 731-1095 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.
Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
Measured: 36 Month
Safety and Effectiveness Outcome
Safety outcome measures between 0-1460 days and Effectiveness outcome measures between 1096-1460 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.
Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month."
Measured: 48 Month
Safety and Effectiveness Outcome
Safety and Effectiveness outcome measures between implant procedure and 60 months. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.
Measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE), secondary procedures, loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
Measured: 60 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2017
- Study completion2 Mar 2023
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 (2)Papers the sponsor has linked to this study.
- Other trials for Aortic Aneurysm, ThoracicStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ali Azizzadeh, MD, Principal investigator, Cedars-Sinai Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652949
- Sponsor's protocol ID
- 10219498DOC
- Other IDs
- NCT02652949
- Acronym
- VEVO
- Status last verified
- Mar 2024
- First submitted
- 8 Jan 2016
- Last updated
- 9 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Verzini F, Cieri E, Kahlberg A, Sternbach Y, Heijmen R, Ouriel K, Robaina S, Azizzadeh A. A preliminary analysis of late structural failures of the Navion stent graft in the treatment of descending thoracic aortic aneurysms. J Vasc Surg. 2021 Oct;74(4):1125-1134.e2. doi: 10.1016/j.jvs.2021.04.018. Epub 2021 Apr 20.
PubMed 33892122Azizzadeh A, Desai N, Arko FR 3rd, Panneton JM, Thaveau F, Hayes P, Dagenais F, Lei L, Verzini F. Pivotal results for the Valiant Navion stent graft system in the Valiant EVO global clinical trial. J Vasc Surg. 2019 Nov;70(5):1399-1408.e1. doi: 10.1016/j.jvs.2019.01.067. Epub 2019 May 21.
PubMed 31126765