Clinical trial NCT02625324: Valiant Evo International Clinical Trial
Official title: Valiant Evo International Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Aneurysm, Thoracic
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2015-12-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
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
timeFrame: 30 Days
Secondary outcomes:
measure: Safety and Effectiveness Outcome
timeFrame: 30 Days
measure: Safety and Effectiveness Outcome
timeFrame: 6 Month
measure: Safety and Effectiveness Outcome
timeFrame: 12 Month
measure: Safety and Effectiveness Outcome
timeFrame: 24 Month
measure: Safety and Effectiveness Outcome
timeFrame: 36 Month
measure: Safety and Effectiveness Outcome
timeFrame: 48 month
measure: Safety and Effectiveness Outcome
timeFrame: 60 Month
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre - Victoria Hospital
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Le Plessis-Robinson
country: France
facility: Centre Chirurgical Marie Lannelongue
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Arnaud de Villeneuve
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil
city: Bologna
country: Italy
facility: Policlinico Sant' Orsola - Malpighi
city: Milano
country: Italy
facility: IRCCS Ca' Granda Ospendale Maggiore Policlinico
city: Milano
country: Italy
facility: Ospedale San Raffaele - Milano
city: Perugia
country: Italy
facility: Università di Perugia - Ospedale S.M. Della Misericordia
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum (MUMC)
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust - St Mary's Hospital
city: London
country: United Kingdom
facility: Saint George's Healthcare NHS Trust
Study officials:
affiliation: A.O.U. Citta della Salute e della Scienza
name: Fabio Verzini, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.