AAA-SHAPE_NLD: Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - Netherlands
Study Details
Study Description
Brief Summary
To determine the safety and efficacy of IMPEDE-FX Embolization Plug and/or IMPEDE-FX Rapid Fill to fill an abdominal aortic aneurysm (AAA) sac outside of an endovascular aneurysm repair (EVAR) stent graft.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Intervention
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Device: IMPEDE-FX Embolization Plug
Fill an abdominal aortic aneurysm (AAA) sac outside of an endovascular aneurysm repair (EVAR) stent graft
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Outcome Measures
Primary Outcome Measures
- Incidence of related major adverse events (MAEs) [30 days post-procedure]
Incidence of related major adverse events (MAEs)
- Efficacy - Technical Success [Immediately after the intervention]
Technical success, defined as filling of the residual flow lumen of the AAA sac with investigational products
Secondary Outcome Measures
- Incidence of related major adverse events (MAEs) [2 years post-procedure]
Incidence of related major adverse events (MAEs)
- Incidence of related serious adverse events (SAEs) [2 years post-procedure]
Incidence of related serious adverse events (SAEs)
- Efficacy - Type II endoleaks [2 years post-procedure]
Incidence of type II endoleaks
- Efficacy - Type I and type III endoleaks [2 years post-procedure]
Incidence of type I and type III endoleaks
- Efficacy - AAA sac diameter/volume [2 years post-procedure]
Change in AAA sac diameter/volume
- Efficacy - Open repair [2 years post-procedure]
Rate of conversion to open AAA repair
- Efficacy - Reinterventions [2 years post-procedure]
Rate of other reinterventions related to the AAA sac growth and/or complications
Eligibility Criteria
Criteria
Inclusion Criteria:
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≥18 years of age
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A candidate for elective EVAR of an infrarenal aortic aneurysm ≥5.5 cm in diameter in men and ≥5.0 cm in women
Exclusion Criteria:
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An inability to provide informed consent
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Enrolled in another clinical study
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Aortoiliac aneurysm, or concomitant iliac artery ectasia or aneurysm (common iliac artery diameter >24 mm) close to the bifurcation and/or that cannot be adequately sealed
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Patent AAA sac feeding vessels (within the sac) >4 mm in diameter
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Volume of AAA sac to be filled after stent graft placement <20 mL or >135 mL, based on pre-procedure CTA (i.e. aortic flow volume exclusive of stent graft volume)
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Use of aortic stent grafts other than the Gore Excluder AAA Endoprosthesis, Cook Zenith Flex AAA Endovascular Graft, or Medtronic Endurant II Stent Graft to treat the AAA
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Planned use of the chosen stent graft outside its instructions for use (IFU)
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Planned use of fenestrated or chimney stent grafts
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Study participants in which stent graft placement is abandoned for any reason, and/or in which the investigator decides, during the course of the stent graft placement, that the study procedure may not be appropriate
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Planned use of embolic devices other than the investigational product to embolize the AAA sac
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Vascular disease and/or anatomy that preclude the safe access and positioning of a catheter to deliver the investigational product into the AAA sac
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Ruptured, leaking, or mycotic (infected) aneurysm
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Aneurysmal disease of the descending thoracic aorta
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Coagulopathy or uncontrolled bleeding disorder
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Long-term (>6 months prior to the procedure) use of direct oral anticoagulant or any vitamin K antagonist anticoagulant use
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Serum creatinine level >2.5 mg/dL;
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Cerebrovascular accident within 3 months prior to the procedure
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Myocardial infarction and/or major heart surgery within 3 months prior to the procedure
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Atrial fibrillation that is not well rate controlled
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Unable or unwilling to comply with study follow-up requirements
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Life expectancy of <2 years post-procedure
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Known hypersensitivity or contraindication to platinum, iridium, or polyurethane
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A condition that inhibits radiographic visualization during the implantation procedure
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History of allergy to contrast medium that cannot be managed medically
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Uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the study
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Pregnant or a lactating female. For females of child-bearing potential, based on a positive pregnancy test within 7 days prior to the procedure or refusal to use a medically accepted method of birth control for the duration of the study
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Prisoner or member of other vulnerable population.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Rijnstate Hospital | Arnhem | Gelderland | Netherlands | 6800 TA |
2 | Dijklander Ziekenhuis | Hoorn | Noord-Holland | Netherlands | 1624 NP |
3 | ETZ Elisabeth | Tilburg | Netherlands | 5022 GC |
Sponsors and Collaborators
- Shape Memory Medical, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRD1020