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Valiant Evo International Clinical Trial

Primary Purpose

Aortic Aneurysm, Thoracic

Status

Completed

Phase

Not Applicable

Locations

International

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 Patient Informed Consent approved by the Sponsor and by the Ethics Committee for this study
Subject presents a 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 MRI 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)
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, 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

Sites / Locations

London Health Sciences Centre - Victoria Hospital
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
Odense Universitetshospital
Centre Chirurgical Marie Lannelongue
CHU de Montpellier - Hôpital Arnaud de Villeneuve
Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil
Policlinico Sant' Orsola - Malpighi
IRCCS Ca' Granda Ospendale Maggiore Policlinico
Ospedale San Raffaele - Milano
Università di Perugia - Ospedale S.M. Della Misericordia
IRCCS Policlinico San Donato
Maastricht Universitair Medisch Centrum (MUMC)
St. Antonius Ziekenhuis
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
Imperial College Healthcare NHS Trust - St Mary's Hospital
Saint George's Healthcare NHS Trust

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: 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, stent graft migration compared to 1 month imaging, aneurysm expansion greater than 5 mm compared to 1 month imaging, and endoleaks.

Full Information

NCT ID

NCT02625324

First Posted

December 2, 2015

Last Updated

August 4, 2023

Sponsor

Medtronic Cardiovascular

1. Study Identification

Unique Protocol Identification Number

NCT02625324

Brief Title

Valiant Evo International Clinical Trial

Official Title

Valiant Evo International Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 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

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of the Valiant Evo International 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 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 Patient Informed Consent approved by the Sponsor and by the Ethics Committee for this study Subject presents a 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 MRI 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 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, 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

Fabio Verzini, Prof.

Organizational Affiliation

A.O.U. Citta della Salute e della Scienza

Official's Role

Principal Investigator

Facility Information:

Facility Name

London Health Sciences Centre - Victoria Hospital

City

London

Country

Canada

Facility Name

Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)

City

Quebec

Country

Canada

Facility Name

Odense Universitetshospital

City

Odense

Country

Denmark

Facility Name

Centre Chirurgical Marie Lannelongue

City

Le Plessis-Robinson

Country

France

Facility Name

CHU de Montpellier - Hôpital Arnaud de Villeneuve

City

Montpellier

Country

France

Facility Name

Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil

City

Strasbourg

Country

France

Facility Name

Policlinico Sant' Orsola - Malpighi

City

Bologna

Country

Italy

Facility Name

IRCCS Ca' Granda Ospendale Maggiore Policlinico

City

Milano

Country

Italy

Facility Name

Ospedale San Raffaele - Milano

City

Milano

Country

Italy

Facility Name

Università di Perugia - Ospedale S.M. Della Misericordia

City

Perugia

Country

Italy

Facility Name

IRCCS Policlinico San Donato

City

San Donato Milanese

Country

Italy

Facility Name

Maastricht Universitair Medisch Centrum (MUMC)

City

Maastricht

Country

Netherlands

Facility Name

St. Antonius Ziekenhuis

City

Nieuwegein

Country

Netherlands

Facility Name

Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

City

Cambridge

Country

United Kingdom

Facility Name

Imperial College Healthcare NHS Trust - St Mary's Hospital

City

London

Country

United Kingdom

Facility Name

Saint George's Healthcare NHS Trust

City

London

Country

United Kingdom

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

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Valiant Evo International Clinical Trial

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