Abdominal Aortic Aneurysm Clinical Trial
— AAA-SHAPE_NLDOfficial title:
Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - A Prospective Multicenter Study
Verified date | May 2022 |
Source | Shape Memory Medical, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 15 |
Est. completion date | July 1, 2024 |
Est. primary completion date | April 13, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - =18 years of age - 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: - An inability to provide informed consent - Enrolled in another clinical study - 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 - Patent AAA sac feeding vessels (within the sac) >4 mm in diameter - 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) - 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 - Planned use of the chosen stent graft outside its instructions for use (IFU) - Planned use of fenestrated or chimney stent grafts - 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 - Planned use of embolic devices other than the investigational product to embolize the AAA sac - Vascular disease and/or anatomy that preclude the safe access and positioning of a catheter to deliver the investigational product into the AAA sac - Ruptured, leaking, or mycotic (infected) aneurysm - Aneurysmal disease of the descending thoracic aorta - Coagulopathy or uncontrolled bleeding disorder - Long-term (>6 months prior to the procedure) use of direct oral anticoagulant or any vitamin K antagonist anticoagulant use - Serum creatinine level >2.5 mg/dL; - Cerebrovascular accident within 3 months prior to the procedure - Myocardial infarction and/or major heart surgery within 3 months prior to the procedure - Atrial fibrillation that is not well rate controlled - Unable or unwilling to comply with study follow-up requirements - Life expectancy of <2 years post-procedure - Known hypersensitivity or contraindication to platinum, iridium, or polyurethane - A condition that inhibits radiographic visualization during the implantation procedure - History of allergy to contrast medium that cannot be managed medically - Uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the study - 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 - Prisoner or member of other vulnerable population. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Rijnstate Hospital | Arnhem | Gelderland |
Netherlands | Dijklander Ziekenhuis | Hoorn | Noord-Holland |
Netherlands | ETZ Elisabeth | Tilburg |
Lead Sponsor | Collaborator |
---|---|
Shape Memory Medical, Inc. |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of related major adverse events (MAEs) | Incidence of related major adverse events (MAEs) | 30 days post-procedure | |
Primary | Efficacy - Technical Success | Technical success, defined as filling of the residual flow lumen of the AAA sac with investigational products | Immediately after the intervention | |
Secondary | Incidence of related major adverse events (MAEs) | Incidence of related major adverse events (MAEs) | 2 years post-procedure | |
Secondary | Incidence of related serious adverse events (SAEs) | Incidence of related serious adverse events (SAEs) | 2 years post-procedure | |
Secondary | Efficacy - Type II endoleaks | Incidence of type II endoleaks | 2 years post-procedure | |
Secondary | Efficacy - Type I and type III endoleaks | Incidence of type I and type III endoleaks | 2 years post-procedure | |
Secondary | Efficacy - AAA sac diameter/volume | Change in AAA sac diameter/volume | 2 years post-procedure | |
Secondary | Efficacy - Open repair | Rate of conversion to open AAA repair | 2 years post-procedure | |
Secondary | Efficacy - Reinterventions | Rate of other reinterventions related to the AAA sac growth and/or complications | 2 years post-procedure |
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