Thoracoabdominal Aortic Aneurysm
Conditions
Keywords
aortic aneurysm
Brief summary
The primary purpose of this study is to assess the use of the TAAA Debranching Stent Graft System to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy, as measured by device safety, effectiveness, costs of delivery of aortic surgery care, and patient quality of life domains. Additionally, the study will assess technical success and treatment success at each follow-up interval.
Detailed description
The primary objective of this clinical investigation is to assess the use of the TAAA Debranching Stent Graft System to repair thoracoabdominal aortic aneurysms. While surgery remains a standard treatment for complex abdominal and thoracoabdominal aneurysms (TAAA), the tolerance of some patients to recover from such extensive and invasive open aortic reconstructions is poor. Endovascular repair may offer the opportunity to reduce patient risk with less invasive approaches, improve quality of life, and serve to reduce the cost burden. The primary technical safety endpoint is freedom from major adverse events (MAE) at 30 days or during hospitalization if this exceeds 30 days. The primary effectiveness endpoint is the proportion of study subjects with treatment success at 1 year.
Interventions
Endovascular stent graft system
DEVICEUnitary Manifold
Endovascular stent graft system
Endovascular stent graft system
Sponsors
Johns Hopkins University
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
Modified 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 4.5 cm Other 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: * ≥ 2.5 cm of healthy/nondiseased tissue (including previously placed graft material) (neck) distal to the left subclavian artery (LSA) diameter in the range of 26-42 mm * ≥2.5cm of surgical graft distal to the left subclavian artery (LSA) diameter in the range of 26-42mm. * 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 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 * Patency of the four major visceral vessels (SMA, celiac, right renal, left renal) * Age: ≥ 18 years old * Life expectancy: \> 1 year
Exclusion criteria
General exclusion * Patient is a good candidate for and elects 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 investigational device exemption (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 * Patient is pregnant or breastfeeding * Patient has a contained rupture * Patient has a ruptured aneurysm * Patient has a dissection in the treated portion of the aorta * Obstructive stenting of any or all of the visceral vessels Medical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Major Adverse Events (MAEs) at 30 Days | 30 days | Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Success at 1 Year | 1 year | Treatment success is defined as a composite of technical success and freedom from the following: Aneurysm enlargement, Aneurysm rupture, Aneurysm-related mortality, Conversion to open repair, Secondary intervention for migration, Type I and III endoleaks, device integrity failure, and patency-related events. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Primary Study Arm The TAAA Debranching Stent Graft System is comprised of two investigational devices including the Visceral Manifold and Thoracic Bifurcation and the unitary manifold. The thoracic bifurcation and the visceral manifold as well as the unitary manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.
Visceral Manifold and Thoracic Bifurcation: Endovascular stent graft system
Unitary Manifold: Endovascular stent graft system
TAAA Debranching Stent Graft System: Endovascular stent graft system | 2 |
| Expanded Selection Arm The Expanded Selection Arm will be treated the same as those in the Primary Study Arm. Your doctor will determine what arm you are in. TAAA Debranching Stent Graft System is comprised of two investigational devices including the Visceral Manifold and Thoracic Bifurcation and the unitary manifold. The thoracic bifurcation and the visceral manifold as well as the unitary manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.
Visceral Manifold and Thoracic Bifurcation: Endovascular stent graft system
Unitary Manifold: Endovascular stent graft system
TAAA Debranching Stent Graft System: Endovascular stent graft system | 0 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 0 |
Baseline characteristics
| Characteristic | Primary Study Arm | Expanded Selection Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 0 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 0 Participants | 2 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 | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 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 | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 0 Participants | 2 Participants |
| Region of Enrollment United States | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 2 | 0 / 0 |
| other Total, other adverse events | 0 / 2 | 0 / 0 |
| serious Total, serious adverse events | 1 / 2 | 0 / 0 |
Outcome results
Primary
Freedom From Major Adverse Events (MAEs) at 30 Days
Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke.
Time frame: 30 days
Population: Enrolled patients with non-staged, completed procedures were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Study Arm | Freedom From Major Adverse Events (MAEs) at 30 Days | 1 Participants |
| Expanded Selection Arm | Freedom From Major Adverse Events (MAEs) at 30 Days | 0 Participants |
Secondary
Treatment Success at 1 Year
Treatment success is defined as a composite of technical success and freedom from the following: Aneurysm enlargement, Aneurysm rupture, Aneurysm-related mortality, Conversion to open repair, Secondary intervention for migration, Type I and III endoleaks, device integrity failure, and patency-related events.
Time frame: 1 year
Population: Enrolled patients with non-staged, completed procedures were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Study Arm | Treatment Success at 1 Year | 0 Participants |
| Expanded Selection Arm | Treatment Success at 1 Year | 0 Participants |