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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valiant Mona LSA Stent Graft System | Experimental | TEVAR procedure using Medtronic Stent Graft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valiant Mona LSA Stent Graft System | Device | All subjects will be implanted with this device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month |
| 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. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Roselli, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanger Heart and Vascular Institute | Charlotte | North Carolina | 28203 | United States | ||
| Cleveland Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26483004 | Derived | Roselli EE, Arko FR 3rd, Thompson MM; Valiant Mona LSA Trial Investigators. Results of the Valiant Mona LSA early feasibility study for descending thoracic aneurysms. J Vasc Surg. 2015 Dec;62(6):1465-71.e3. doi: 10.1016/j.jvs.2015.07.078. Epub 2015 Oct 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | Includes active subjects in the ITT population at 30 days post-index procedure. | Posted | Number | participants | 1 month |
|
|
Through 30 days
Investigators are required to assess for adverse events at each follow-up timepoint, including discharge, 30 days, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months. Per protocol, all adverse events are required to be reported, regardless of relationship.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Taryn Dellaripa, Principal Clinical Research Specialist | Medtronic Vascular | 541-301-3181 | taryn.dellaripa@medtronic.com |
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| ID | Term |
|---|---|
| D017545 | Aortic Aneurysm, Thoracic |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Cleveland |
| Ohio |
| 27465 |
| United States |
| St George's Vascular Institute, St. George's Hospital | London | United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | 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. | Posted | Number | participants | 1 month |
|
|
|
| 7 |
| 9 |
| 3 |
| 9 |
| Cardiac Failure | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cardiovascular Deconditioning | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal Hernia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vascular Pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Cerebellar Infarction | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cerebrovascular Accident | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hemianopia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Confusional State | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Paranoia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Peripheral Ischaemia | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
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| D001018 |
| Aortic Diseases |