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Valiant Evo US Clinical Trial (VEVO)

Primary Purpose

Aortic Aneurysm, Thoracic

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Valiant Evo Thoracic Stent Graft System

About this trial

This is an interventional treatment trial for Aortic Aneurysm, Thoracic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:
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
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
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:

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).
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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endovascular Repair

Arm Description

Valiant Evo Thoracic Stent Graft System

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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."

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.

Full Information

NCT ID

NCT02652949

First Posted

January 8, 2016

Last Updated

June 27, 2023

Sponsor

Medtronic Cardiovascular

1. Study Identification

Unique Protocol Identification Number

NCT02652949

Brief Title

Valiant Evo US Clinical Trial

Acronym

VEVO

Official Title

Valiant Evo US Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

April 2016 (Actual)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

March 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Cardiovascular

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Aneurysm, Thoracic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Endovascular Repair

Arm Type

Experimental

Arm Description

Valiant Evo Thoracic Stent Graft System

Intervention Type

Device

Intervention Name(s)

Valiant Evo Thoracic Stent Graft System

Intervention Description

Procedure: thoracic endovascular aneurysm repair (TEVAR)

Primary Outcome Measure Information:

Title

Description

Time Frame

30 Days

Secondary Outcome Measure Information:

Title

Safety and Effectiveness Outcome

Description

Time Frame

30 Days

Title

Safety and Effectiveness Outcome

Description

Time Frame

6 month

Title

Safety and Effectiveness Outcome

Description

Time Frame

12 Month

Title

Safety and Effectiveness Outcome

Description

Time Frame

24 Month

Title

Safety and Effectiveness Outcome

Description

Time Frame

36 Month

Title

Safety and Effectiveness Outcome

Description

Time Frame

48 Month

Title

Safety and Effectiveness Outcome

Description

Time Frame

60 Month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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). 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ali Azizzadeh, MD

Organizational Affiliation

Cedars-Sinai Heart Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Abrazo Arizona Heart Institute

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85006

Country

United States

Facility Name

Stanford Hospital

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Medstar Washington Hospital Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Facility Name

Emory University Hospital

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

University of Michigan Health System

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

University of Minnesota Medical Center

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

Barnes Jewish Hospital

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Albany Medical Center

City

Albany

State/Province

New York

ZIP/Postal Code

12208

Country

United States

Facility Name

University of North Carolina

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27514

Country

United States

Facility Name

Carolinas Medical Center

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28203

Country

United States

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Cleveland Clinic

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Ohio State University

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

OhioHealth Riverside Methodist Hospital

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43214

Country

United States

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Memorial Hermann Texas Medical Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

The Heart Hospital Baylor Plano

City

Plano

State/Province

Texas

ZIP/Postal Code

75093

Country

United States

Facility Name

University of Virginia Medical Center

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Facility Name

Inova Fairfax Hospital

City

Falls Church

State/Province

Virginia

ZIP/Postal Code

22042

Country

United States

Facility Name

Sentara Norfolk General Hospital

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33892122

Citation

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.

Results Reference

derived

PubMed Identifier

31126765

Citation

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.

Results Reference

derived

Learn more about this trial

Valiant Evo US Clinical Trial

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Valiant Evo US Clinical Trial (VEVO)

Aortic Aneurysm, Thoracic

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial