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

Sponsor
Shape Memory Medical, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04751578
Collaborator
(none)
15
3
1
35.6
5
0.1

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
  • Device: IMPEDE-FX Embolization Plug
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - A Prospective Multicenter Study
Actual Study Start Date :
Jul 13, 2021
Actual Primary Completion Date :
Apr 13, 2022
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Incidence of related major adverse events (MAEs) [30 days post-procedure]

    Incidence of related major adverse events (MAEs)

  2. 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

  1. Incidence of related major adverse events (MAEs) [2 years post-procedure]

    Incidence of related major adverse events (MAEs)

  2. Incidence of related serious adverse events (SAEs) [2 years post-procedure]

    Incidence of related serious adverse events (SAEs)

  3. Efficacy - Type II endoleaks [2 years post-procedure]

    Incidence of type II endoleaks

  4. Efficacy - Type I and type III endoleaks [2 years post-procedure]

    Incidence of type I and type III endoleaks

  5. Efficacy - AAA sac diameter/volume [2 years post-procedure]

    Change in AAA sac diameter/volume

  6. Efficacy - Open repair [2 years post-procedure]

    Rate of conversion to open AAA repair

  7. Efficacy - Reinterventions [2 years post-procedure]

    Rate of other reinterventions related to the AAA sac growth and/or complications

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

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.
Responsible Party:
Shape Memory Medical, Inc.
ClinicalTrials.gov Identifier:
NCT04751578
Other Study ID Numbers:
  • CRD1020
First Posted:
Feb 12, 2021
Last Update Posted:
May 31, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 31, 2022