Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - Netherlands

Abdominal Aortic Aneurysm Clinical Trial

— AAA-SHAPE_NLD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04751578
• Other study ID #: CRD1020
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Endoleak

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