Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - Netherlands (AAA-SHAPE_NLD)

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

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 Overview

• Status: Active, not recruiting
• Conditions: Abdominal Aortic Aneurysm
• Intervention / Treatment: Device: IMPEDE-FX Embolization Plug

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Tilburg, Netherlands, 5022 GC
    • ETZ Elisabeth
  • Gelderland
    • Arnhem, Gelderland, Netherlands, 6800 TA
      • Rijnstate Hospital
  • Noord-Holland
    • Hoorn, Noord-Holland, Netherlands, 1624 NP
      • Dijklander ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Device: IMPEDE-FX Embolization Plug; Fill an abdominal aortic aneurysm (AAA) sac outside of an endovascular aneurysm repair (EVAR) stent graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of related major adverse events (MAEs)	Incidence of related major adverse events (MAEs)	30 days post-procedure
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of related major adverse events (MAEs)	Incidence of related major adverse events (MAEs)	2 years post-procedure
Incidence of related serious adverse events (SAEs)	Incidence of related serious adverse events (SAEs)	2 years post-procedure
Efficacy - Type II endoleaks	Incidence of type II endoleaks	2 years post-procedure
Efficacy - Type I and type III endoleaks	Incidence of type I and type III endoleaks	2 years post-procedure
Efficacy - AAA sac diameter/volume	Change in AAA sac diameter/volume	2 years post-procedure
Efficacy - Open repair	Rate of conversion to open AAA repair	2 years post-procedure
Efficacy - Reinterventions	Rate of other reinterventions related to the AAA sac growth and/or complications	2 years post-procedure

Collaborators and Investigators

• Sponsor: Shape Memory Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2021
• Primary Completion (Actual): April 13, 2022
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 26, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Hemorrhage; Aortic Diseases; Postoperative Hemorrhage; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Endoleak
• Other Study ID Numbers: CRD1020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes