A localized enlargement of the aorta (biggest blood vessel in the body) below the kidneys
Conditions
Interventions
Endovascular Aneurysm Repair (EVAR).
Sponsors
Johnson & Johnson
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or Female * 18 years of age. 2. Proximal aortic neck is 17-31mm in diameter. 3. Supra-renal aorta at 20mm above the intended landing location is smaller than the nominal diameter of the aortic bifurcate prosthesis to be used. 4. Infra-renal aortic neck is: * 10mm in length with supra-renal and infra-renal neck angulations * 60°. 5. Subject has at least one of the following: a. AAA size > 5.0 cm b. Increase of the AAA diameter of >0.5 cm over the last 6 months 6. Abdominal treatment length (lowest renal artery origin to the aortic bifurcation) of * 9.4cm. 7. Aortic bifurcation > 18mm in diameter. 8. Iliac landing zone * 15mm in length. 9. Iliac landing zone 7-22mm in diameter. 10. Minimum access vessel size of * 5mm. 11. Minimum overall AAA treatment length (from lowest renal artery to distal landing zone) of 128mm. 12. Understands study requirements and treatment procedures, signs the informed consent form prior to any study procedure, and is willing to comply with all specified follow-up evaluations.
Exclusion criteria
Exclusion criteria: 1. Vascular anatomy in which the placement of the stent-graft will cause occlusion of both internal iliac arteries or necessitates surgical occlusion of both internal iliac arteries. 2. Subject has one of the following : a. Aneurysm sac rupture or leaking abdominal aortic aneurysm; b. Mycotic, dissecting, or inflammatory abdominal aortic aneurysm; c. Clinically significant acute vascular injury due to trauma. 3. Significant aortic or iliac mural thrombus, calcification, or plaque that would compromise fixation and seal of the device. 4. A reversed conical aortic neck defined as > 3mm distal increase over a 10mm length in the planned seal zone. 5. Thoracic aortic aneurysm * 45mm. 6. Any aortic dissection. 7. Morbid obesity (BMI of > 40.0kg/m2) or other clinical conditions that limit required imaging studies or visualization of the aorta. 8. Renal insufficiency (Creatinine > 2.0mg/dL (= 177µmol/L)) or on renal dialysis. 9. Known allergy or intolerance to nickel titanium (nitinol), Polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE). 10. Known contraindication to undergoing angiography or anticoagulation (e.g. contrast allergies which cannot be treated). 11. Connective tissue disorder (such as Marfan's Syndrome or Ehler's-Danlos Syndrome). 12. Coagulopathy, bleeding disorder, or other hypercoagulable state. 13. Organ transplant recipient or subject requiring systemic immunosuppressant therapy. 14. Cerebral Vascular Accident (CVA), MI or intracranial bleeding within 3 months prior to the procedure. 15. Active infection or chronic systemic illness at the time of the index procedure that may interfere with the study objectives. 16. Major surgical procedure within 1 month prior to index procedure or pre-planned within 1 month afterwards. 17. Co-existing condition with a life expectancy of less than 2 years at time of procedure. 18. Current or planned participation in any another investigational drug or medical device clinical study that has not completed primary endpoint(s) evaluation. 19. Existing AAA surgical graft and/or a AAA stent-graft system. 20. Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial. 21. 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 |
|---|---|
| The primary endpoints are defined as follows: 1. Efficacy: successful aneurysm repair (absence of type I or III endoleak) within 30 days post-procedure as confirmed by contrast CT-scan. 2. Safety: the absence of major adverse events (death, MI, CVA and renal failure) within 30 days post-procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are defined as follows: 1. Absence of aneurysm enlargement - defined as an increase in maximum aortic diameter/circumference/cross sectional area of more than 10% or in total aneurysm volume of more than 5% at 1 year, 3 years, and 5 years post-procedure compared to the baseline CT assessment performed within 30 days by quantitative AAA measurements. 2. Absence of stent-graft migration assessed at 1 year, 3 years, and 5 years post-procedure compared to the baseline evaluation within 30 days post-procedure. 3. Absence of stent-graft fractures assessed within 30 days, 6 months, and annually through 5 years post-procedure. 4. Absence of endoleak (types I or III) at 1 year, 3 years, and 5 years post-procedure. 5. Absence of endoleak type IV. 6. Absence of deployment-related complications within 30 days, 6 months, and annually through 5 years post-procedure. 7. Absence of device-related complications within 30 days, 6 months, and annually through 5 years post-procedure. 8. Absence of systemic complications within 30 days, 6 months, and annually through 5 years post-procedure. 9. Pain post-operatively compared to external comparator, as measured by the SF36v2 at screening, 30 days, 6 months, 1 year follow up. 10. Physical functioning post-operatively compared to external comparator, as measured by the SF36v2 at screening, 30 days, 6 months, 1 year follow up. 11. Procedure-related clinical utility measures evaluated through subgroup analyses. | — |
Countries
Netherlands
Outcome results
None listed