Thoracoabdominal Aortic Aneurysms
Conditions
Brief summary
The purpose of this study is to evaluate the use of an investigational device called the ValiantTM Visceral Manifold Thoracoabdominal Stent Graft System for the repair of thoracoabdominal aortic aneurysms (TAAA), which is a balloon-like bulge in the aorta (major artery leading away from your heart) that originates in your chest and extends to your abdomen and also includes the branch arteries that supply blood to the liver, spleen, intestine, kidneys and other organs in your abdomen. The word investigational means the device is still being tested and is not approved by the Food and Drug Administration (FDA) for sale in the United States.
Detailed description
The primary objective of the clinical investigation is to assess the use of the thoracic bifurcation and the visceral manifold 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). Additionally, the study will assess technical success and treatment success at each follow-up interval.
Interventions
DEVICEValiant™Thoracoabdominal Stent Graft System
The Visceral Manifold System is comprised of the Thoracic Bifurcation and Visceral Manifold to treat a thoracoabdominal aortic aneurysm or TAAA. The experimental procedure to implant the stent graft will be done in an operating room and will last anywhere from four to eight hours, but may take longer.
Sponsors
NYU Langone Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Primary Arm 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 \> 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 \> 0.5 cm in 6 months * Saccular aneurysm deemed at significant risk for rupture * Symptomatic aneurysm greater than or equal to 4.5 cm Additional Primary Arm Inclusion Criteria: * 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: (a) ≥ 2.5 cm of nonaneurysmal aortic segment including previously placed graft material (neck) distal to the left subclavian artery (LSA); (b) Diameter in the range of 26-42 mm; (c) 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 * 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 * Life expectancy: \> 1 year Expanded Use Arm Inclusion Criteria: * Branch vessel diameter \<5mm * Urgent or emergent presentation * Patient has a contained rupture * Patient has a ruptured aneurysm * Patient has a type B dissection (subacute or chronic) in the portion of the aorta intended to be treated * Poor performance status including two major system failures (cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular) * Baseline creatinine greater than 2.0 mg/dL * Anatomy that does not allow maintenance of at least one hypogastric artery * Anatomy that does not allow primary or assisted patency of the left subclavian artery * Prior aneurysm repair that would involve relining of the previously placed graft material requiring placement of the investigational system in a landing zone that expands beyond any limits of the previously placed graft material * Obstructive stenting of any or all of the visceral vessels * Treatment of the patient population listed above will be considered for this expanded arm of the study if they are not a candidate for open surgical repair, cannot be treated with approved devices, and do not meet inclusion into the primary study arm as per opinion of the Principal Investigator, with the concurrence of the IRB. Primary Arm
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 prosthesis * 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 by patient or legal representative * 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 (cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular) * Prior aneurysm repair that would involve relining of the previously placed graft material requiring placement of the investigational system in a landing zone that expands beyond any limits of the previously placed graft material * Known sensitivities or allergies to the materials of construction of the devices, including nitinol (Nickel: Titanium), polyester, platinum-iridium, polytetrafluoroethylene (PTFE), platinum, gold, polyethylene, or stainless steel. * Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed * Uncorrectable coagulopathy * Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment * Patient has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned \< 30 days of the endovascular repair * Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina) * Systemic or local infection that may increase the risk of endovascular graft infection * Baseline creatinine greater than 2.0 mg/dL * History of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome) * ranch vessel diameter less than 5 mm * Thrombus or excessive calcification within the neck of the aneurysm * Anatomy that would not allow maintenance of at least one patent hypogastric artery * Anatomy that would not allow primary or assisted patency of the left subclavian artery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Major Adverse Events (MAE) at Day 30 | Up to Day 30 | Freedom from MAE is defined as the number of participants who have not experienced a major adverse event (including death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke) at 30 days. |
| Number of Participants Who Achieve Technical Success | Up to Year 1 | Technical success is defined as successful access of the aneurysm site and deployment of the Visceral Manifold investigational devices in intended locations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Paraplegia at Day 30 | Up to Day 30 | Number of participants who have not experienced paraplegia at Day 30. |
Countries
United States
Participant flow
Pre-assignment details
17 individuals were enrolled in the study; however, 7 of these individuals did not start the study. Thus, the total number of participants who started the study is n=10.
Participants by arm
| Arm | Count |
|---|---|
| Primary Arm: Treatment With Valiant Thoracoabdominal Stent Graft System The implantation of the Valiant Thoracoabdominal Stent Graft System is conducted under fluoroscopic/angiographic guidance.
Valiant™Thoracoabdominal Stent Graft System: The Visceral Manifold System is comprised of the Thoracic Bifurcation and Visceral Manifold to treat a thoracoabdominal aortic aneurysm or TAAA. The experimental procedure to implant the stent graft will be done in an operating room and will last anywhere from four to eight hours, but may take longer. | 5 |
| Expanded Use Arm: Treatment With Valiant Thoracoabdominal Stent Graft System The implantation of the Valiant Thoracoabdominal Stent Graft System is conducted under fluoroscopic/angiographic guidance.
Valiant™Thoracoabdominal Stent Graft System: The Visceral Manifold System is comprised of the Thoracic Bifurcation and Visceral Manifold to treat a thoracoabdominal aortic aneurysm or TAAA. The experimental procedure to implant the stent graft will be done in an operating room and will last anywhere from four to eight hours, but may take longer. | 5 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Primary Arm: Treatment With Valiant Thoracoabdominal Stent Graft System | Total | Expanded Use Arm: Treatment With Valiant Thoracoabdominal Stent Graft System |
|---|---|---|---|
| Age, Continuous | 72.6 years STANDARD_DEVIATION 7 | 70.1 years STANDARD_DEVIATION 11.7 | 67.6 years STANDARD_DEVIATION 15.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 10 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 5 Participants | 6 Participants | 1 Participants |
| Region of Enrollment United States | 5 participants | 10 participants | 5 participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 5 | 3 / 5 |
| other Total, other adverse events | 5 / 5 | 5 / 5 |
| serious Total, serious adverse events | 5 / 5 | 4 / 5 |
Outcome results
Primary
Freedom From Major Adverse Events (MAE) at Day 30
Freedom from MAE is defined as the number of participants who have not experienced a major adverse event (including death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke) at 30 days.
Time frame: Up to Day 30
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Arm: Treatment With Valiant Thoracoabdominal Stent Graft System | Freedom From Major Adverse Events (MAE) at Day 30 | 3 Participants |
| Expanded Use Arm: Treatment With Valiant Thoracoabdominal Stent Graft System | Freedom From Major Adverse Events (MAE) at Day 30 | 4 Participants |
Primary
Number of Participants Who Achieve Technical Success
Technical success is defined as successful access of the aneurysm site and deployment of the Visceral Manifold investigational devices in intended locations.
Time frame: Up to Year 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Arm: Treatment With Valiant Thoracoabdominal Stent Graft System | Number of Participants Who Achieve Technical Success | 5 Participants |
| Expanded Use Arm: Treatment With Valiant Thoracoabdominal Stent Graft System | Number of Participants Who Achieve Technical Success | 4 Participants |
Secondary
Freedom From Paraplegia at Day 30
Number of participants who have not experienced paraplegia at Day 30.
Time frame: Up to Day 30
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Arm: Treatment With Valiant Thoracoabdominal Stent Graft System | Freedom From Paraplegia at Day 30 | 3 Participants |
| Expanded Use Arm: Treatment With Valiant Thoracoabdominal Stent Graft System | Freedom From Paraplegia at Day 30 | 4 Participants |