Valiant Evo US Clinical Trial

NCT02652949 | Completed Results DMC FDA Device

• 2 other identifiers: 10219498DOCNCT02652949
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 21

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.

Conditions

Aortic Aneurysm, Thoracic

Outcome Measures

Primary Outcomes (1)

• 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.

  30 Days

Secondary Outcomes (7)

• Safety and Effectiveness Outcome

  30 Days

• Safety and Effectiveness Outcome

  6 month

• Safety and Effectiveness Outcome

  12 Month

• Safety and Effectiveness Outcome

  24 Month

• Safety and Effectiveness Outcome

  36 Month

Study Arms (1)

Endovascular Repair

EXPERIMENTAL

Valiant Evo Thoracic Stent Graft System

Device: Valiant Evo Thoracic Stent Graft System

Interventions

Valiant Evo Thoracic Stent Graft System DEVICE

Procedure: thoracic endovascular aneurysm repair (TEVAR)

Endovascular Repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (21)

Abrazo Arizona Heart Institute

Phoenix, Arizona, 85006, United States

Location

Stanford Hospital

Stanford, California, 94305, United States

Location

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Memorial Hermann Texas Medical Center

Houston, Texas, 77030, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Related Publications (2)

• 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.

  PMID: 33892122 DERIVED

• 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.

  PMID: 31126765 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Limitations and Caveats

Clinical evidence collected as part of the Valiant Evo US Clinical Trial (NCT02652949) and the Valiant Evo International Clinical Trial (NCT02625324) are combined to support commercial marketing approvals.

Results Point of Contact

• Title: Rianna Rapson - Clinical Study Manager
• Organization: Medtronic

rianna.k.rapson@medtronic.com

763-526-2170

Study Officials

• Ali Azizzadeh, MD

  Cedars-Sinai Heart Institute

  PRINCIPAL INVESTIGATOR

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: January 8, 2016
• First Posted: January 12, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: March 2, 2023
• Last Updated: April 9, 2024
• Results First Posted: February 26, 2019

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)