aneurysms endoleak
Conditions
Interventions
Open Surgical Repair OSR:
The traditional treatment for AAA is elective open surgery that involves
a large abdominal incision and placement of a synthetic graft sutured from the
proximal end of the
Sponsors
Endoron Medical Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 And 2 or 3: 2. Subject has a previously implanted Medtronic Endurant II/IIs Stent Graft, Gore Excluder AAA Endoprosthesis, or Gore Excluder Conformable AAA Endoprosthesis and a.Has neck diameter between 19 mm and 29 mm with a AAA neck length of = 10mm, And b or c: b.Has experienced a loss or a lack of endovascular graft seal or fixation as evidenced by one or more of the following: i. Type 1a endoleak ii. Migration, as evidenced by one of the following: • = 5 mm of migration, with an indication for intervention • Anterior bowing of the graft iii. Fractures in the endovascular graft Or c.Has one or more imaging observations, placing the endovascular graft at risk of losing seal or fixation, including any of the following: i.Suspected occult Type 1a endoleak ii.Disease progression/inadequate oversizing as evidenced by one or more of the following: • Reduced length of apposition compared to post-op CT, in absence of migration • > 3 mm neck dilatation compared to previous post-op CT • Nominal endovascular graft diameter not at least 10% greater than the measured luminal diameter iii.A conical neck, with a maximum of 4mm distal increase over a 10 mm length Or 3. Subjects diagnosed with a AAA and planned treatment with the Medtronic Endurant II/IIs Stent Graft, Gore Excluder AAA Endoprosthesis, or Gore Excluder Conformable AAA Endoprosthesis, and has: a. AAA proximal neck internal diameter between 19mm and 29mm, and b. An internal diameter at the aortic bifurcation = 18 mm c. Iliac landing zone diameters with a range of 8 to 25mm d. Morphology suitable for endovascular aneurysm repair e. Adequate iliac or femoral access that is compatible with vascular access techniques, devices, or accessories And f or g: f. Has a AAA neck length of at least 10mm Or g. Has a conical neck with a maximum of 4mm distal increase over a 10mm length in a patient at high risk for morbidity and mortality with open surgical repair And has the following: 4. A patent iliac or femoral artery that allows endovascular access to the aneurysmal site with the selected Aortoseal Endostapling System (i.e., 18Fr or 20Fr) 5. Infrarenal neck angulation of = 60° for the Endurant II/IIs or Gore Excluder AAA Endoprosthesis, or = 75° for the Gore Excluder Conformable AAA Endoprosthesis
Exclusion criteria
Exclusion criteria: 1. An inability to provide informed consent 2. Enrolled in any other interventional clinical study that could interfere with the outcomes associated with the endpoints for this study 3. Unable or unwilling to comply with study requirements. 4. More than minimal thrombus, calcification, and/or plaque in the intended implantation level of the Aortoseal in the aorta 5. Planned use of aortic cuff to provide complete exclusion of the AAA prior to introduction of the Aortoseal Endostapling System into the vasculature 6. Insufficient circumferential apposition of the endovascular graft to the aorta 7. Insufficient length of apposition (< 8 mm) of the endovascular graft to the aortic neck 8. Planned use of HeliFX EndoAnchor system 9. Concomitant thoracoabdominal aortic aneurysms 10. Other aortic reconstructive surgery anticipated in the next 12 months 11. Requires emergent AAA surgery 12. Ruptured AAA 13. Mycotic or inflammatory AAA 14. Known genetic connective tissue disorders that may affect the vasculature (e.g., Marfan or Ehlers-Danlos Syndromes). 15. Previous open surgical AAA repair 16. Myocardial infarction and/or major heart surgery within the past 4 weeks 17. Serum creatinine > 2.0 mg/dL which prevents completion of CT with contrast 18. Active systemic infection 19. History of bleeding diathesis or hypercoagulable condition and thrombocytopenia 20. Cerebrovascular incident within 12 weeks prior to the procedure 21. History of allergy to or intolerance of radiopaque contrast agents that cannot be managed medically 22. Known sensitivity or allergy to implant materials 23. Body habitus that would prevent imaging required by the study 24. Significant comorbid conditions that pose undue risk of general anesthesia or endovascular surgery 25. Requires additional planned major procedure at the time of AAA repair or within 30 days before or after AAA repair 26. Pregnant or a lactating female. For females of childbearing potential, based on a positive pregnancy test within 7 days prior to the procedure and/or refusal to use a medically accepted method of birth control for the duration of the study. 27. Life expectancy < 2 years Post-endograft deployment: 28. Any observation that would negatively impact the interpretation of the study outcomes or successful use of the Aortoseal (e.g., MAE prior to introduction of the Aortoseal into the vasculature, use of a cuff or HeliFX, < 8 mm length of apposition of the endovascular graft to the aortic neck) 29. Subject with vasculitis disease and connective tissue disease neck
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The STUDY does not have defined primary endpoints nor any powered endpoints. The SEAL Study is not hypothesis driven. All endpoints will be analyzed descriptively. The limitation of the design for this study is that there are no pass/fail criteria from a statistical hypothesis testing. All endpoints will be analyzed descriptively. Event rates will be analyzed by calculating the distribution frequencies and the associated 1- sided 95% confidence limits using an exact method. In general, qualitative parameters will be described by their distribution frequencies; quantitative parameters will be described by their mean, standard deviation, minimum, maximum, median, and number of subjects with assessable data. For events, such as AEs, deaths and secondary interventions, that can occur or are observed at any time during the study, no time window will be applied. For such events, an event that occurs *within 30 days* is an event that takes place between Days 0 to 30, inclusive. Similarly, an event that occurs *within 365 days* is an event occurring between Day 0 to Day 365, inclusive. Date of event onset will be used to determine when the event occurred. Day 0 is referring to the day of index procedure (Aortoseal procedure). 10.3. Sub-Groups/Data Presentation Patients enrolled in the study will either have the Aortoseal Endostapling System implanted at the same time as the Medtronic Endurant/Endurant II/IIs Endovascular Graft or in a secondary procedure. Data will be presented descriptively as one combined cohort. | — |
Secondary
| Measure | Time frame |
|---|---|
| see above | — |
Countries
Greece, Israel, Netherlands, Poland
Contacts
Public ContactLimor Dinur Klein
Endoron Medical Ltd.
Outcome results
None listed