To evaluate the safety of IMPEDE-FX Embolization Plug and/or IMPEDE-FX RapidFill to fill a AAA sac outside of an EVAR stent graft, and the efficacy of the IMPEDE-FX Embolization Plugs to reduce the volume and/or diameter of the AAA sac and/or the…
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints are:
• Incidence of related major adverse events (MAEs*), from the day of procedure
through 30 days post-procedure. Relatedness to the investigational
product/procedure to be adjudicated by the independent safety monitor.
• Rate of technical success, defined as filling of the residual flow lumen of
the AAA sac with investigational products, based on pre-procedure CTA and
intra-procedural contrast-angiography of the residual blood lumen
(*lumenogram*).
Secondary outcome
Other endpoints include the rate of adverse events through 5 years, the rates
of endoleaks and other EVAR-related complications, and changes in sac size
(diameter and volume) through 5 years.
Background summary
An abdominal aortic aneurysm (AAA) is an enlarged area in the lower aorta. Over
time, this enlargement can become weak and the force of normal blood pressure
can cause it to expand and rupture. This can lead to haemorrhage and death.
Endovascular aneurysm repair (EVAR) is a standard of care procedure to treat
AAAs. Complications of EVAR include endoleaks. Endoleak is defined as
persistent blood flow in the aneurysm sac (the area outside the stent graft)
after EVAR. Furthermore, failure of a AAA sac to decrease in size after EVAR
has been linked to shorter long-term survival.
It has been shown that filling the AAA sac with material, including embolic
material, contributes to a reduction in the number of endoleaks and consequent
reinterventions, and a stabilization/decrease in the size of the AAA sac.
The shape memory polymer in the investigational product is a porous embolic
scaffold and may contribute to a reduction in the number of endoleaks and
consequent reinterventions, and a stabilization/decrease in the size of the AAA
sac. This polymer is already clinically applied for embolization of peripheral
vasculature. The purpose of this study is to evaluate the IMPEDE-FX
Embolization Plug and/ or IMPEDE-FX RapidFill for filling the AAA-sac outside
of the EVAR-stent graft.
Study objective
To evaluate the safety of IMPEDE-FX Embolization Plug and/or IMPEDE-FX
RapidFill to fill a AAA sac outside of an EVAR stent graft, and the efficacy of
the IMPEDE-FX Embolization Plugs to reduce the volume and/or diameter of the
AAA sac and/or the rate of other post-EVAR complications.
Study design
A prospective, multicenter, single-arm, open-label, post-market interventional
clinical investigation with marketed medical devices being investigated for a
new indication.
Intervention
The application of the embolization plug to reduce the volume and/or diameter
of the AAA sac post-EVAR.
Study burden and risks
The study procedure is performed immediately following elective standard of
care EVAR (in the same procedure). Baseline assessments are in line with
standard of care EVAR. An additional tube of blood may be drawn, depending on
study site standard of care for blood tests prior to EVAR. Preparation for the
procedure is in line with standard of care EVAR. The process of filling the sac
with investigational product after the EVAR stent graft is in place extends the
procedure by as much time is necessary to insert the devices into the AAA sac.
The amount of extra time needed is estimated to be approximately 25 min.
The follow-up regimen is similar to standard of care for EVAR: study
participants are required to attend study follow-up visits at 30 days, 6
months, 1 year, and 2-5 years. Computed tomography (CT)-based imaging and
ultrasound imaging and a blood draw (through 6 months) will occur at these
visits. Depending on study site standard of care follow-up for EVAR, the study
participant may undergo an additional CT scan at 6 months and 2-5 years for the
study. Again, depending on study site standard of care follow-up for EVAR, the
ultrasound scan at 30 days and 1-5 year may be in addition to standard of care.
The types of risks associated with the procedure are similar to those for
standard of care EVAR and literature reports of AAA sac filling. The potential
benefits are that the AAA sac filling reduces the volume and/or diameter of the
AAA sac and/or the rate of endoleaks and other post-EVAR complications.
Aldo Avenue, Suite 109 807
Santa Clara CA 95054
US
Aldo Avenue, Suite 109 807
Santa Clara CA 95054
US
Listed location countries
Age
Inclusion criteria
1. >=18 years of age.
2. 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
1. An inability to provide informed consent.
2. Enrolled in another clinical study.
3. 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.
4. Patent AAA sac feeding vessels (within the sac) >4 mm in diameter.
5. 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).
6. 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.
7. Planned use of the chosen stent graft outside its instructions for use (IFU).
8. Planned use of fenestrated or chimney stent grafts.
9. 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.
10. Planned use of embolic devices other than the investigational product to
embolize the AAA sac.
11. Vascular disease and/or anatomy that preclude the safe access and
positioning of a catheter to deliver the investigational product into the AAA
sac.
12. Ruptured, leaking, or mycotic (infected) aneurysm.
13. Aneurysmal disease of the descending thoracic aorta.
14. Coagulopathy or uncontrolled bleeding disorder.
15. Long-term (>6 months prior to the procedure) use of direct oral
anticoagulant or any vitamin K antagonist anticoagulant use.
16. Serum creatinine level >2.5 mg/dL.
17. Cerebrovascular accident within 3 months prior to the procedure.
18. Myocardial infarction and/or major heart surgery within 3 months prior to
the procedure.
19. Atrial fibrillation that is not well rate controlled.
20. Unable or unwilling to comply with study follow-up requirements.
21. Life expectancy of <2 years post-procedure.
22. Known hypersensitivity or contraindication to platinum, iridium, or
polyurethane.
23. A condition that inhibits radiographic visualization during the
implantation procedure.
24. History of allergy to contrast medium that cannot be managed medically.
25. Uncontrolled co-morbid medical condition, including mental health issues,
that would adversely affect participation in the study.
26. 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.
27. Member of a vulnerable population.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04751578 |
| CCMO | NL76926.091.21 |