Valiant Evo International Clinical Trial

Not Applicable

Completed

Conditions: Aortic Aneurysm, Thoracic

Interventions: Device: Valiant Evo Thoracic Stent Graft System

Registration Number: NCT02625324

Lead Sponsor: Medtronic Cardiovascular

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 100

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endovascular repair	Valiant Evo Thoracic Stent Graft System	Valiant Evo Thoracic Stent Graft System

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
Safety and Effectiveness Outcome	60 Month	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.

Trial Locations

Locations (16): Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
🇨🇦
Quebec, Canada
Policlinico Sant' Orsola - Malpighi
🇮🇹
Bologna, Italy
Saint George's Healthcare NHS Trust
🇬🇧
London, United Kingdom
Centre Chirurgical Marie Lannelongue
🇫🇷
Le Plessis-Robinson, France
CHU de Montpellier - Hôpital Arnaud de Villeneuve
🇫🇷
Montpellier, France
Imperial College Healthcare NHS Trust - St Mary's Hospital
🇬🇧
London, United Kingdom
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
🇬🇧
Cambridge, United Kingdom
Maastricht Universitair Medisch Centrum (MUMC)
🇳🇱
Maastricht, Netherlands
Università di Perugia - Ospedale S.M. Della Misericordia
🇮🇹
Perugia, Italy
IRCCS Policlinico San Donato
🇮🇹
San Donato Milanese, Italy
Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil
🇫🇷
Strasbourg, France
St. Antonius Ziekenhuis
🇳🇱
Nieuwegein, Netherlands
Odense Universitetshospital
🇩🇰
Odense, Denmark
IRCCS Ca' Granda Ospendale Maggiore Policlinico
🇮🇹
Milano, Italy
Ospedale San Raffaele - Milano
🇮🇹
Milano, Italy
London Health Sciences Centre - Victoria Hospital
🇨🇦
London, Canada