Valiant Evo US Clinical Trial

Not Applicable

Completed

• Conditions: Aortic Aneurysm, Thoracic
• Interventions: Device: Valiant Evo Thoracic Stent Graft System

• Registration Number: NCT02652949
• Lead Sponsor: Medtronic Cardiovascular

Brief 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.

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.

Study Timeline

• Study First Submitted: 2016-01-08
• Study First Submitted QC: 2016-01-08
• Study First Posted: 2016-01-12
• Study Start: 2016-04
• Primary Completion: 2017-12
• Results First Submitted: 2018-12-10
• Results First Submitted QC: 2019-02-07
• Results First Posted: 2019-02-26
• Study Completion: 2023-03-02
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Subject is ≥18 years old.

2. Subject understands and voluntarily has signed and dated the Informed Consent Form approved by the Sponsor and by the Ethics Committee for this study.

3. 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

4. Subject has a DTAA that is one of the following:

   1. A fusiform aneurysm with a maximum diameter that:

      • is ≥ 50 mm and/or:
      • 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

   2. A saccular aneurysm or a penetrating atherosclerotic ulcer

5. 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:

   1. Proximal and distal non-aneurysmal aortic neck diameter measurements must be ≥ 16 mm and ≤ 42 mm;
   2. 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.
   3. Distal non-aneurysmal aortic neck length must be ≥ 20 mm

6. 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.

Exclusion Criteria

1. Subject has a life expectancy of less than 1 year
2. Subject is participating in another investigational drug or device study which would interfere with the endpoints and follow-ups of this study.
3. Subject is pregnant.
4. Subject requires planned placement of the covered proximal end of the stent graft to occur in zones 0 or 1.
5. Subject has a thoracic aneurysm with a contained rupture or localized at the anastomosis of a previous graft (pseudo-/false aneurysm).
6. Subject has a mycotic aneurysm.
7. Subject has a dissection (type A or B) or an intramural hematoma or an aortic rupture in addition to the thoracic aneurysm.
8. Subject requires emergent aneurysm treatment, e.g., trauma or rupture.
9. 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.
10. Subject requires surgical or endovascular treatment of an infra-renal aneurysm at the time of implant
11. Subject has had previous surgical or endovascular treatment of an infra-renal aortic aneurysm.
12. 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.
13. 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).
14. 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.
15. Subject has a connective tissue disease (e.g., Marfan's syndrome, aortic medial degeneration).
16. Subject has a bleeding diathesis or coagulopathy, or refuses blood transfusion.
17. Subject has had a Myocardial Infarction (MI) within 3 months of the procedure.
18. Subject has had a Cerebrovascular Accident (CVA) within 3 months of the procedure.
19. Subject has a known allergy or intolerance to the device materials
20. Subject has a known allergy to anesthetic drugs
21. Subject has a known hypersensitivity or contraindication to anticoagulants, or contrast media, which is not amenable to pretreatment.
22. Subject has active or systemic infection at the time of the index procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endovascular Repair	Valiant Evo Thoracic Stent Graft System	Valiant Evo Thoracic Stent Graft System

Primary Outcome Measures

Name	Time	Method
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	30 Days	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.

Secondary Outcome Measures

Name	Time	Method
Safety and Effectiveness Outcome	60 Month	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.

Trial Locations

Locations (21)

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Albany Medical Center; 🇺🇸 Albany, New York, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

OhioHealth Riverside Methodist Hospital; 🇺🇸 Columbus, Ohio, United States

University of Minnesota Medical Center; 🇺🇸 Minneapolis, Minnesota, United States

Abrazo Arizona Heart Institute; 🇺🇸 Phoenix, Arizona, United States

Stanford Hospital; 🇺🇸 Stanford, California, United States

Medstar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States

Barnes Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

The Heart Hospital Baylor Plano; 🇺🇸 Plano, Texas, United States

University of Virginia Medical Center; 🇺🇸 Charlottesville, Virginia, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Memorial Hermann Texas Medical Center; 🇺🇸 Houston, Texas, United States

Inova Fairfax Hospital; 🇺🇸 Falls Church, Virginia, United States

Sentara Norfolk General Hospital; 🇺🇸 Norfolk, Virginia, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States