Aortic Aneurysm, ThoracicNCT02625324

Valiant Evo International Clinical Trial

A study testing Valiant Evo Thoracic Stent Graft System in people with Aortic Aneurysm, Thoracic, run by Medtronic Cardiovascular at 16 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Aortic Aneurysm, Thoracic
What is being tested?: Valiant Evo Thoracic Stent Graft System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 16 sitesin 6 countries
Study dates: Apr 2016to 2 Mar 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:

Show all 14Show fewer

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.

Who cannot join

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

Show all 22Show fewer

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

Trial locations and contacts

16 sites in 6 countries.

Country

City, postcode or hospital

16 sites in 6 countries

Italy5 sites

Policlinico Sant' Orsola - Malpighi
Bologna
IRCCS Ca' Granda Ospendale Maggiore Policlinico
Milan
Ospedale San Raffaele - Milano
Milan
Università di Perugia - Ospedale S.M. Della Misericordia
Perugia
IRCCS Policlinico San Donato
San Donato Milanese

Other trials in Italy

France3 sites

Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson
CHU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier
Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil
Strasbourg

Other trials in France

United Kingdom3 sites

Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
Cambridge
Imperial College Healthcare NHS Trust - St Mary's Hospital
London
Saint George's Healthcare NHS Trust
London

Other trials in United Kingdom

Canada2 sites

London Health Sciences Centre - Victoria Hospital
London
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
Québec

Other trials in Canada

Netherlands2 sites

Maastricht Universitair Medisch Centrum (MUMC)
Maastricht
St. Antonius Ziekenhuis
Nieuwegein

Other trials in Netherlands

Denmark1 site

Odense Universitetshospital
Odense

Other trials in Denmark

About this study

Read the 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.

Conditions: Aortic Aneurysm, Thoracic
Being tested: Valiant Evo Thoracic Stent Graft System
Medical subject headings: Aortic Aneurysm, Thoracic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Valiant Evo Thoracic Stent Graft SystemDevice
Procedure: thoracic endovascular aneurysm repair (TEVAR)

Study groups in NCT02625324
Study group	Role	What they receive
Endovascular repair	Experimental	Valiant Evo Thoracic Stent Graft System Receives: Device: Valiant Evo Thoracic Stent Graft System

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 30 Days

Secondary outcomes (7)

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.
Measured: 30 Days
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.
Measured: 6 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.
Measured: 12 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.
Measured: 24 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.
Measured: 36 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.
Measured: 48 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.
Measured: 60 Month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 20162 Mar 2023

First posted9 Dec 2015 (estimated)
Study startApr 2016
Primary completionDec 2017
Study completion2 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Aortic Aneurysm, ThoracicStudies of the same condition, open and under way.
More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02625324
Sponsor's protocol ID: 10219493DOC
Other IDs: NCT02625324
Status last verified: Mar 2024
First submitted: 2 Dec 2015
Last updated: 9 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 33892122
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.
PubMed 31126765

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Aortic Aneurysm, Thoracic trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Valiant Evo International Clinical Trial
ClinicalTrials.gov ID: NCT02625324
Acronym / sponsor ID: 10219493DOC
Conditions: Aortic Aneurysm, Thoracic
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Medtronic CardiovascularIndustry (pharma, biotech, devices)
Study start: Apr 2016 (actual)
Primary completion: Dec 2017 (actual)
Study completion: 2 Mar 2023 (actual)
First posted: 9 Dec 2015 (estimated)
Results: Posted 15 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Endovascular repair	Experimental	Device: Valiant Evo Thoracic Stent Graft SystemValiant Evo Thoracic Stent Graft System

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

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:
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:

Key exclusion criteria (22 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Valiant Evo Thoracic Stent Graft SystemProcedure: thoracic endovascular aneurysm repair (TEVAR)	Device	Endovascular repair

Primary outcome

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
Time frame: 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.

7 secondary outcomes

Safety and Effectiveness Outcome
Time frame: 30 Days
Safety and Effectiveness Outcome
Time frame: 6 Month
Safety and Effectiveness Outcome
Time frame: 12 Month
Safety and Effectiveness Outcome
Time frame: 24 Month
Safety and Effectiveness Outcome
Time frame: 36 Month
Safety and Effectiveness Outcome
Time frame: 48 month
Safety and Effectiveness Outcome
Time frame: 60 Month

Results and safety

Results posted to the registry on 15 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Endovascular Repair	87	86

Primary outcome: 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

Time frame: 30 Days. Count of participants. Unit: Participants

Measure	Endovascular Repair n = 87
Value	2

Endovascular Repair: Event Rate: 0.023, p <0.0001, Exact binomial test

Population analysed: The 30-day primary endpoint was evaluated for Premarket Approval (PMA) when 87 subjects completed 30 day follow-up.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months, 48 Months, and 60 Months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Endovascular Repair 30-Day Secondary Endpoint	32 of 100 (32%)	62 of 100 (62%)	2 of 100
Endovascular Repair 6-Month Secondary Endpoint	27 of 98 (27.6%)	32 of 98 (32.7%)	6 of 99
Endovascular Repair 12-Month Secondary Endpoint	22 of 91 (24.2%)	20 of 91 (22%)	10 of 97
Endovascular Repair 24-Month Secondary Endpoint	17 of 84 (20.2%)	21 of 84 (25%)	13 of 80
Endovascular Repair 36-Month Secondary Endpoint	14 of 66 (21.2%)	14 of 66 (21.2%)	14 of 78
Endovascular Repair 48-Month Secondary Endpoint	17 of 62 (27.4%)	16 of 62 (25.8%)	20 of 71
Endovascular Repair 60-Month Secondary Endpoint	15 of 49 (30.6%)	14 of 49 (28.6%)	23 of 66

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33892122Verzini 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.
Derived from this study: PubMed 31126765Azizzadeh 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fabio Verzini, Prof. principal investigator

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

16 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Valiant Evo Thoracic Stent Graft System in people with Aortic Aneurysm, Thoracic, run by Medtronic Cardiovascular at 16 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Italy, France, United Kingdom, Canada, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 30 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02625324, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.