Valiant Evo US Clinical Trial

NCT ID: NCT02652949

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2023-03-02

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.

Conditions

Aortic Aneurysm, Thoracic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endovascular Repair

Valiant Evo Thoracic Stent Graft System

Group Type: EXPERIMENTAL

Valiant Evo Thoracic Stent Graft System

Intervention Type: DEVICE

Procedure: thoracic endovascular aneurysm repair (TEVAR)

Interventions

Valiant Evo Thoracic Stent Graft System

Procedure: thoracic endovascular aneurysm repair (TEVAR)

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ali Azizzadeh, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Heart Institute

Locations

Abrazo Arizona Heart Institute

Phoenix, Arizona, United States

Stanford Hospital

Stanford, California, United States

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States

University of Florida

Gainesville, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Barnes Jewish Hospital

St Louis, Missouri, United States

Albany Medical Center

Albany, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Carolinas Medical Center

Charlotte, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, 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 Pennsylvania

Philadelphia, Pennsylvania, United States

Memorial Hermann Texas Medical Center

Houston, Texas, United States

The Heart Hospital Baylor Plano

Plano, Texas, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33892122 (View on PubMed)

Azizzadeh 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.

Reference Type: DERIVED

PMID: 31126765 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

NCT02652949

Identifier Type: OTHER

Identifier Source: secondary_id

10219498DOC

Identifier Type: -

Identifier Source: org_study_id