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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04751578
Other study ID # CRD1020
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 13, 2021
Est. completion date July 1, 2024

Study information

Verified date May 2022
Source Shape Memory Medical, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Intervention

Device:
IMPEDE-FX Embolization Plug
Fill an abdominal aortic aneurysm (AAA) sac outside of an endovascular aneurysm repair (EVAR) stent graft

Locations

Country Name City State
Netherlands Rijnstate Hospital Arnhem Gelderland
Netherlands Dijklander Ziekenhuis Hoorn Noord-Holland
Netherlands ETZ Elisabeth Tilburg

Sponsors (1)

Lead Sponsor Collaborator
Shape Memory Medical, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

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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