Abdominal Aortic Aneurysm
Conditions
Keywords
Abdominal Aortic Aneurysm, AAA, TriVascular Stent-Graft System, Stent-Graft
Brief summary
This study was a prospective observational study examined the safety of the TriVascular AAA Stent-Graft System in the elective treatment of patients with abdominal aortic aneurysms. Specifically, the study will evaluate the safety of the TriVascualr AAA Stent-Graft System, evaluate the ability to deliver the Tri-Vascular AAA Stent-Graft System to the desired location within the aorta, and evaluate the ability of the TriVascular AAA Stent-Graft to exclude the abdominal aortic aneurysm.
Interventions
DEVICETriVascular Stent-Graft System
TriVascular Stent-Graft System
Sponsors
Boston Scientific Corporation
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
* Male or infertile female * Have signed an informed consent form. * Are considered an appropriate candidate for open surgical repair of an abdominal aortic aneurysm. * at least one of the following: Abdominal aortic aneurysm \>= 4.5 cm in diameter; aneurysm has increased in size by 0.5cm in last 6 months; maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an adjacent normal aortic segment; saccular aneurysm larger than 3 cm. * Have patent iliac or femoral arteries that allow endovascular access to the aneurysmal site with a 17F Delivery Catheter.
Exclusion criteria
* A dissecting, acutely ruptured, or leaking aneurysm, or an acute vascular injury due to trauma. * A need for emergent surgery. * contraindication to undergoing angiography. * A Thoracic aortic aneurysm that requires treatment. * Presence of thrombus or atheroma in proximal aortic neck covering \> 50% of the endoluminal surface. * Presence of diffuse atherosclerotic disease in either common iliac artery that reduces the iliac artery diameter to \<7mm. * Congenital abnormalities in which the placement of the stent-graft will cause occlusion of major arterial flow. Such abnormalities should be evaluated(e.g. angiography or CT) prior to treatment. * Unstable angina * Morbid obesity or other clinical conditions that severely inhibit x-ray visualization of the aorta. * Connective tissue disease (e.g., Marfan's or Ehlers-Danlos syndrome.) * Hypercoagulable state. * Contraindication for anticoagulation. * Acute renal failure. * Active systemic infection. * less than 18 years of age. * Life expectancy less than 1 year. * Current, or anticipated participation within 1 year, in another research study involving an investigational device or new drug (with the exception of participation in the Lifeline Registry of Endovascular Therapy). * Other medical, social, or psychological issues that in the opinion of the investigator preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Without a Device Related Adverse Events Within 1 Month of the Study Procedure. | 1 month | Device related adverse events included, but were not limited to: Stent Graft Migration, Vessel dissection or perforation, stent graft occlusion, branch vessel occlusion, aneurysm rupture. |
| Number of Participants Without a Type I, III, and/or IV Endoleak at 1 Month Follow-up Identified by Computed Tomography (CT). | 1 month | A Type I endoleak is a persistent perigraft channel of blood flow that develops due to inadequate or ineffective seal at the graft ends (attachment zones). A Type III endoleak occurs in the midgraft region due to leakage through a defect in the graft fabric or between the segments of a multisegmental graft. A Type IV endoleak is seen on completion of angiography or subsequent contrast studies as any blush of contrast that is presumed to emanate from blood diffusion across the porous graft fabric or through small holes in the graft cause by sutures or stent struts. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieve Technical Success of the Stent Graft System. | Post procedure | Technical success was defined as successful introduction of the delivery catheter into the arterial system at the time of the study procedure and successful delivery/deployment of the stent graft system to the intended location with the absence of device related surgical conversion and intra-operative mortality. Device related surgical conversion is defined as the inability to deliver or deploy the stent graft system, then subsequently surgically treating the patient. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TriVascular Stent Graft This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow. | 43 |
| Total | 43 |
Baseline characteristics
| Characteristic | TriVascular Stent Graft |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 39 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age Continuous | 73.1 years STANDARD_DEVIATION 7.9 |
| Region of Enrollment United States | 43 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 33 / 43 |
| serious Total, serious adverse events | 35 / 43 |
Outcome results
Primary
Number of Participants Without a Device Related Adverse Events Within 1 Month of the Study Procedure.
Device related adverse events included, but were not limited to: Stent Graft Migration, Vessel dissection or perforation, stent graft occlusion, branch vessel occlusion, aneurysm rupture.
Time frame: 1 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TriVascular Stent Graft | Number of Participants Without a Device Related Adverse Events Within 1 Month of the Study Procedure. | 36 Participants |
Primary
Number of Participants Without a Type I, III, and/or IV Endoleak at 1 Month Follow-up Identified by Computed Tomography (CT).
A Type I endoleak is a persistent perigraft channel of blood flow that develops due to inadequate or ineffective seal at the graft ends (attachment zones). A Type III endoleak occurs in the midgraft region due to leakage through a defect in the graft fabric or between the segments of a multisegmental graft. A Type IV endoleak is seen on completion of angiography or subsequent contrast studies as any blush of contrast that is presumed to emanate from blood diffusion across the porous graft fabric or through small holes in the graft cause by sutures or stent struts.
Time frame: 1 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TriVascular Stent Graft | Number of Participants Without a Type I, III, and/or IV Endoleak at 1 Month Follow-up Identified by Computed Tomography (CT). | 0 Participants |
Secondary
Number of Participants Who Achieve Technical Success of the Stent Graft System.
Technical success was defined as successful introduction of the delivery catheter into the arterial system at the time of the study procedure and successful delivery/deployment of the stent graft system to the intended location with the absence of device related surgical conversion and intra-operative mortality. Device related surgical conversion is defined as the inability to deliver or deploy the stent graft system, then subsequently surgically treating the patient.
Time frame: Post procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TriVascular Stent Graft | Number of Participants Who Achieve Technical Success of the Stent Graft System. | 42 Participants |