Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks – Netherlands

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - Netherlands

Official Title

Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - A Prospective Multicenter Study

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.

Study Type

Interventional

Primary Outcome

Incidence of related major adverse events (MAEs)

Secondary Outcome

 Incidence of related major adverse events (MAEs)

Condition

Abdominal Aortic Aneurysm

Intervention

IMPEDE-FX Embolization Plug

Study Arms / Comparison Groups

 Intervention
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

15

Start Date

July 13, 2021

Completion Date

July 1, 2024

Primary Completion Date

April 13, 2022

Eligibility Criteria

        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.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations

NCT ID

NCT04751578

Organization ID

CRD1020

Responsible Party

Sponsor

Study Sponsor

Shape Memory Medical, Inc.

Study Sponsor

, ,

Verification Date

May 2022