Thoracic Aortic Aneurysms
Conditions
Keywords
Thoracic Aneurysm, Endovascular Aortic Repair, TEVAR
Brief summary
The Valiant Mona LSA thoracic stent graft system is for the endovascular repair of aneurysms of the descending thoracic aorta (DTA) in patients who require coverage of the left subclavian artery (LSA).The study is intended to assess safety and performance of the device acutely and at 30 days.
Interventions
DEVICEValiant Mona LSA Stent Graft System
All subjects will be implanted with this device
Sponsors
Medtronic Cardiovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is at least 18 years of age. * The subject or legal guardian understands the nature of the study and agrees to its provisions on a written informed consent form * Subject must be considered a candidate for revascularization of the LSA. * Subject has a DTA which will require coverage of the LSA * Subject's anatomy must meet the anatomical criteria to receive that implanted device
Exclusion criteria
* Subject has had previous endovascular repair of the ascending and/or descending thoracic aorta. * Subject is in acute renal failure or has renal insufficiency with a serum creatinine ≥ 2.0 mg/dL * Subject is a pregnant female. * Enrollment in another clinical study * Subject has had a cerebral vascular accident (CVA)or myocardial infarction (MI) within 3 months. * Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion. * Subject has a known allergy or intolerance to the device components. * Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Observation - Rate of Major Adverse Events (MAEs) | 1 month | Major Adverse Events is a composite endpoint that includes Aneurysm Related Mortality (ARM), Stroke, Paraplegia, and Left Arm/Hand Ischemia. |
| Primary Effectiveness Observation | 1 month | Treatment success which is defined as technical success (successful delivery and deployment of the stent graft in the planned location with no unintentional coverage of other vessels, assessed intraoperatively, and the removal of the delivery system) and successful exclusion of the aneurysm while maintaining patency of the MSG and BSG at the 30 day visit. |
Countries
United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Valiant Mona LSA Stent Graft System TEVAR procedure using Medtronic Stent Graft\>
\> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Valiant Mona LSA Stent Graft System |
|---|---|
| Age, Continuous | 72.89 years STANDARD_DEVIATION 7.61 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United Kingdom | 2 participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 9 |
| serious Total, serious adverse events | 7 / 9 |
Outcome results
Primary
Primary Effectiveness Observation
Treatment success which is defined as technical success (successful delivery and deployment of the stent graft in the planned location with no unintentional coverage of other vessels, assessed intraoperatively, and the removal of the delivery system) and successful exclusion of the aneurysm while maintaining patency of the MSG and BSG at the 30 day visit.
Time frame: 1 month
Population: Based on the number of ITT subject with evaluable data, subjects were considered unevaluable for treatment success if the 30 day imaging was unable to assess patency of the MSG and BSG. One subject completed CT imaging at discharge, which was not repeated at the 30 day visit, and, therefore, was not considered evaluable for this assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valiant Mona LSA Stent Graft System | Primary Effectiveness Observation | 8 participants |
Primary
Primary Safety Observation - Rate of Major Adverse Events (MAEs)
Major Adverse Events is a composite endpoint that includes Aneurysm Related Mortality (ARM), Stroke, Paraplegia, and Left Arm/Hand Ischemia.
Time frame: 1 month
Population: Includes active subjects in the ITT population at 30 days post-index procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Valiant Mona LSA Stent Graft System | Primary Safety Observation - Rate of Major Adverse Events (MAEs) | 3 participants |