Valiant Evo International Clinical Trial | NCT02625324

NCT02625324

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
NCT02625324	Other Identifier	ClinicalTrials.gov

Status Module

Description Module

Label	Type	Description	Intervention Names
Endovascular repair	Experimental	Valiant Evo Thoracic Stent Graft System	Device: Valiant Evo Thoracic Stent Graft System

Name	Type	Description	Arm Group Labels	Other Names
Valiant Evo Thoracic Stent Graft System	Device	Procedure: thoracic endovascular aneurysm repair (TEVAR)	Endovascular repair

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	30 Days

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

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:
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

Name	Affiliation	Role
Fabio Verzini, Prof.	A.O.U. Citta della Salute e della Scienza	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
London Health Sciences Centre - Victoria Hospital		London			Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)

PubMed Identifier	Type	Citation	Retractions
33892122	Derived	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.
31126765	Derived

ID	Title	Description
FG000	Endovascular Repair	Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysms (DTAA) and who met the inclusion and exclusion criteria.

Periods

Title

Milestones

Reasons Not Completed

30-Day Follow-up for Primary Endpoint

Type	Comment	Milestone Data
STARTED		FG00087 subjectsThe 30-day primary endpoint was evaluated when 87 subjects completed 30-day follow-up.
COMPLETED		FG00086 subjects
NOT COMPLETED		FG0001 subjects

Type	Comment	Reasons
Death		FG0001 subjects

30-Day Follow-up for Secondary Endpoint

Type	Comment	Milestone Data
STARTED		FG000100 subjectsThe 30-day secondary endpoint was evaluated when 100 subjects completed 30-day follow-up.
COMPLETED		FG00099 subjects
NOT COMPLETED		FG000

6-Month Follow-up Subject Accountability

Type	Comment	Milestone Data
STARTED		FG00099 subjectsNote that 6-month follow up is not mandatory for OUS subjects
COMPLETED		FG00091 subjects
NOT COMPLETED		FG000

12-Month Follow-up Secondary Endpoint

Type	Comment	Milestone Data
STARTED		FG00091 subjects
COMPLETED		FG00087 subjects
NOT COMPLETED		FG000

24-Month Follow-up Secondary Endpoint

Type	Comment	Milestone Data
STARTED		FG00087 subjects
COMPLETED		FG00052 subjects
NOT COMPLETED		FG000

36-Month Follow-up Secondary Endpoint

Type	Comment	Milestone Data
STARTED		FG00052 subjects
COMPLETED		FG00048 subjects
NOT COMPLETED		FG000

48-Month Follow-up Secondary Endpoint

Type	Comment	Milestone Data
STARTED		FG00048 subjects
COMPLETED		FG00042 subjects
NOT COMPLETED		FG000

60-Month Follow-up Secondary Endpoint

Type	Comment	Milestone Data
STARTED		FG00042 subjects
COMPLETED		FG00036 subjects
NOT COMPLETED		FG000

ID	Title	Description
BG000	Endovascular Repair	Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm (DTAA) and who met the inclusion and exclusion criteria. 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]).

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

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

Posted

Count of Participants

Participants

30 Days

ID	Title	Description

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Endovascular Repair 30-Day Secondary Endpoint	Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality, or one or more serious adverse event within 0-30 days Procedure: thoracic endovascular aneurysm repair (TEVAR) For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 30-Day time period or were followed for at least 1 day. For Adverse Events, the 30-Day time period for reporting is 0-30 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 30-Day time interval.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 22, 2017	Dec 10, 2018	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Nov 1, 2017	Dec 10, 2018	SAP_001.pdf

ID	Term
D001014	Aortic Aneurysm
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases