Thoracoabdominal Aortic Aneurysm
Conditions
Keywords
Thoracoabdominal Aortic Aneurysm, Endovascular Aneurysm Repair, Stent-Graft
Brief summary
The primary objective of the clinical investigation is to assess the use of the the Visceral Manifold Thoracoabdominal Aortic Aneurysms (VTAAA) stent graft system to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent of the study is to assess safety (i.e. freedom from major adverse events (MAE) at 30 days) and preliminary effectiveness (i.e., treatment success and technical success) of the device (i.e., the proportion of treatment group subjects that achieve and maintain treatment success at one year).
Detailed description
The primary purpose of this study is to evaluate the safety of this device as there are no or very limited devices and clinical options available for this patient population. The primary safety endpoint of this study is safety freedom from major adverse events (MAE) at 30 days or during hospitalization if this exceeds 30 days. Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke. The primary safety endpoint will be analyzed to determine statistical significance when compared to a target performance goal. A literature review of outcomes of open surgical repair was used to create the performance goal as there is not a comparable endovascular option to use for analysis. The performance goal was selected based on the range of subjects experiencing a major adverse event at 30 days. The range was calculated based on assumptions of the minimum and maximum number of subjects experiencing at least one MAE in the historical open surgical repair group . Based on the literature reviewed and the above assumptions the range of subjects experiencing at least one MAE in the open surgical repair group is 30.5% to 77.4%. The primary effectiveness endpoint is the proportion of the study subjects with treatment success at 1 year. The data will be presented as quality outcomes with the number of study subjects with treatment success compared to the overall patient population. Additionally, data outcomes from this study will be entered into a common vascular database so that data can be pooled with other PS-IDEs. This would provide consistent reporting across the PS-IDEs. Additionally, the PS-IDEs will be evaluating the same device and endpoints to allow for a pool-ability of data across the sites. The pooled data will be separated into two separate study arms: primary study arm and expanded selection arm.
Interventions
DEVICEThoracoabdominal Aortic Aneurysm Repair
Thoracoabdominal aortic aneurysm repair
Sponsors
Medtronic
Vanderbilt University Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Primary Arm General Inclusion Criteria: * A patient may be entered into the study if the patient has at least one of the following: * An aneurysm with a maximum diameter of greater than or equal to 5.5 cm or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements * Aneurysm with a history of growth greater than or equal to 0.5 cm in 6 months * Saccular aneurysm deemed at significant risk for rupture * Symptomatic aneurysm greater than 4.5 cm * Axillary or brachial and iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit * Proximal landing zone for the thoracic bifurcation stent graft that has: * Greater than or equal to 2.5 cm of nonaneurysmal aortic segment including previously placed graft material (neck) distal to the left subclavian artery (LSA) diameter in the range of 26-42 mm * Adequate distance from the celiac artery, in order to accommodate cannulation from the antegrade access point when considering the total deployed length of the thoracic bifurcation and visceral manifold * Minimum branch vessel diameter greater than 5 mm * Iliac artery or aortic distal fixation site, including both native tissue and previously placed graft, greater than or equal to 15 mm in length and diameter in the range of 8 - 25 mm * Age: greater than or equal to 18 years old * Life expectancy: greater than 1 year
Exclusion criteria
* Patient is a good candidate for and elects for open surgical repair * Can be treated in accordance with the instructions for use with a legally marketed endovascular device * Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site * Unwilling to comply with the follow-up schedule * Inability or refusal to give informed consent * Urgent or emergent presentation * Patient is pregnant or breastfeeding * Patient has a contained rupture * Patient has a ruptured aneurysm * Patient has a dissection in the portion of the aorta intended to be treated * Obstructive stenting of any or all of the visceral vessels * Poor performance status including two major system failures (including but not limited to cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular) Medical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoint: Freedom From Major Adverse Events | 30 days | Freedom from major adverse events (MAE) at 30 days. |
| Preliminary Effectiveness | 1 year | Proportion of subjects treated with the device that achieve and maintain treatment success at 1 year. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Safety Endpoint:Freedom From Major Adverse Events | 6 months | Freedom from major adverse events (MAE) at 6 Months. |
| Secondary Safety Endpoint: Freedom From Major Adverse Events | 1 year. | Freedom from major adverse events (MAE) at 1 year. |
| Secondary Effectiveness Assessment | 30 days. | Proportion of subjects treated with the device that achieve and maintain treatment success at 30 days as defined by aneurysm exclusion. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental: Primary Arm Use of the thoracic bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 4 | 0 |
Baseline characteristics
| Characteristic | Experimental: Primary Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 65 years STANDARD_DEVIATION 1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 4 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 4 | 0 / 0 |
| other Total, other adverse events | 0 / 4 | 0 / 0 |
| serious Total, serious adverse events | 4 / 4 | 0 / 0 |
Outcome results
Primary
Preliminary Effectiveness
Proportion of subjects treated with the device that achieve and maintain treatment success at 1 year.
Time frame: 1 year
Population: Data was not collected.
Primary
Safety Endpoint: Freedom From Major Adverse Events
Freedom from major adverse events (MAE) at 30 days.
Time frame: 30 days
Population: No data was collected.
Secondary
Secondary Effectiveness Assessment
Proportion of subjects treated with the device that achieve and maintain treatment success at 5 years as define by aneurysm exclusion.
Time frame: 5 years.
Population: There were no patients alive at 5 years. No data was collected.
Secondary
Secondary Effectiveness Assessment
Proportion of subjects treated with the device that achieve and maintain treatment success at 30 days as defined by aneurysm exclusion.
Time frame: 30 days.
Population: No participants enrolled in the Expanded Selection Arm
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Arm | Secondary Effectiveness Assessment | 3 Participants |
| Expanded Selection Arm | Secondary Effectiveness Assessment | 0 Participants |
Secondary
Secondary Effectiveness Assessment
Proportion of subjects treated with the device that achieve and maintain treatment success at 6 months as defined by aneurysm exclusion.
Time frame: 6 months.
Population: There were no patients alive at 6 months. No data was collected.
Secondary
Secondary Effectiveness Assessment
Proportion of subjects treated with the device that achieve and maintain treatment success at 2 years as defined by aneurysm exclusion.
Time frame: 2 years.
Population: There were no patients alive at 2 years. No data was collected.
Secondary
Secondary Effectiveness Assessment
Proportion of subjects treated with the device that achieve and maintain treatment success at 3 years as defined by aneurysm exclusion.
Time frame: 3 years.
Population: There were no patients alive at 3 years. No data was collected.
Secondary
Secondary Effectiveness Assessment
Proportion of subjects treated with the device that achieve and maintain treatment success at 4 years as define by aneurysm exclusion.
Time frame: 4 years.
Population: There were no patients alive at 4 years. No data was collected.
Secondary
Secondary Safety Endpoint: Freedom From Major Adverse Events
Freedom from major adverse events (MAE) at 1 year.
Time frame: 1 year.
Population: No data collected
Secondary
Secondary Safety Endpoint: Freedom From Major Adverse Events
Freedom from major adverse events (MAE) at 2 years.
Time frame: 2 years.
Population: No data collected
Secondary
Secondary Safety Endpoint: Freedom From Major Adverse Events
Freedom from major adverse events (MAE) at 3 years.
Time frame: 3 years.
Population: No data collected
Secondary
Secondary Safety Endpoint: Freedom From Major Adverse Events
Freedom from major adverse events (MAE) at 4 years.
Time frame: 4 years.
Population: No data collected
Secondary
Secondary Safety Endpoint: Freedom From Major Adverse Events
Freedom from major adverse events (MAE) at 5 years.
Time frame: 5 years.
Population: Data were not collected at this time point as the study was terminated before 5 years
Secondary
Secondary Safety Endpoint:Freedom From Major Adverse Events
Freedom from major adverse events (MAE) at 6 Months.
Time frame: 6 months
Population: No data collected.