Valiant Evo International Clinical Trial

NCT ID: NCT02625324

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 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.

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 Patient Informed Consent approved by the Sponsor and by the Ethics Committee for this study

3. Subject presents a 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 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

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, 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

Fabio Verzini, Prof.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

London Health Sciences Centre - Victoria Hospital

London, , Canada

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

Québec, , Canada

Odense Universitetshospital

Odense, , Denmark

Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, , France

CHU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, , France

Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil

Strasbourg, , France

Policlinico Sant' Orsola - Malpighi

Bologna, , Italy

IRCCS Ca' Granda Ospendale Maggiore Policlinico

Milan, , Italy

Ospedale San Raffaele - Milano

Milan, , Italy

Università di Perugia - Ospedale S.M. Della Misericordia

Perugia, , Italy

IRCCS Policlinico San Donato

San Donato Milanese, , Italy

Maastricht Universitair Medisch Centrum (MUMC)

Maastricht, , Netherlands

St. Antonius Ziekenhuis

Nieuwegein, , Netherlands

Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

Cambridge, , United Kingdom

Imperial College Healthcare NHS Trust - St Mary's Hospital

London, , United Kingdom

Saint George's Healthcare NHS Trust

London, , United Kingdom

Countries

Canada; Denmark; France; Italy; Netherlands; United Kingdom

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

NCT02625324

Identifier Type: OTHER

Identifier Source: secondary_id

10219493DOC

Identifier Type: -

Identifier Source: org_study_id