The leading hypothesis is: Endoleaks type II are prevented when AneuFix is prophylactically used during EVAR procedures. The primary (performance) objective is to assess the feasibility to fill the AAA sac after EVAR during the same procedure, and…
ID
Source
Brief title
Condition
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Technical feasibility of Prophylactic Sac Filling using AneuFix
- Absence of aneurysm sac growth at 6 and 12 months (Clinical success)
Secondary outcome
- Intraoperative occurrence of complications
- Rate of peri-operative complications (<30 days)
- Occurrence of (any type) endoleak
- Occurrence of adverse events and adverse device effects at 1, 6 and 12 months
- Rate of secondary endovascular or surgical re-interventions at 1, 6 and 12
months
- Rate of aneurysm rupture at 6 and 12 months
- Survival throughout the study up until 24 months
Background summary
Endovascular aortic aneurysm repair (EVAR) has become a well-established
treatment modality for most abdominal (infra-renal) aortic aneurysms (AAA)
repair. EVAR, however, has a number of disadvantages. Complications and
reinterventions caused mainly by endoleaks, endotension and stent-graft
migration, and device failure are of major concern. As a result, lifelong
follow-up is needd since these complications can be associated with aneurysm
rupture. The most important complications of EVAR are the possible occurrence
of endoleaks, of which type II endoleaks are the most common. To prevent this
type of endoleaks, papers currently describe the method of IMA (inferior
mesenteric artery) embolization or embolization of large open lumbar arteries.
Typically these methods reduce the incidence of endoleak occurrence and sac
growth by between 25-50%.
The main conclusions from the literature review are:
• Type II endoleaks are frequently occurring post-EVAR; but most resolve
spontaneously in case of early type II endoleaks <6 months
• Only in situations of persistent type II endoleaks >6 months where the
aneurysm sac is growing as a result of the presence of type II endoleaks,
reinterventions are to be considered
• The technical success rates of interventions are typically high: >80%
• The clinical success rates (sac growth stabilization or decrease) over more
than 1 year are typically low: <60%
• None of the current treatment techniques offers the ultimate good solution
• Reinterventions to treat a type II endoleak are expensive
• Preventing endoleaks by embolizing only the IMA or patent lumbars >2mm have
only limited clinical success
• Filling the complete aneurysm sac with a polymer at the moment of EVAR shows
promising results for prevention of endoleaks, as demonstrated in the Nellix
clinical studies
Our hypothesis from the literature is therefore that all of the potential
causes for type II endoleak have their role: a patent IMA, patent lumbars, size
and shape of the aneurysm sac and thrombus present. We therefore postulate that
if we want to obtain a near 100% reduction of the occurrence of endoleak type
II and aneurysm sac growth, we need to occlude all in/outflow blood vessels as
well as obtain a complete filling of the aneurysm sac.
Study objective
The leading hypothesis is: Endoleaks type II are prevented when AneuFix is
prophylactically used during EVAR procedures.
The primary (performance) objective is to assess the feasibility to fill the
AAA sac after EVAR during the same procedure, and to assess the rate of
endoleaks after EVAR followed by the AneuFix procedure.
The secondary objective of the study is to assess the occurrence of type II
endoleaks at 6 and 12 months after EVAR, and aneurysmal sac growth at 6 and 12
months after EVAR. In the analyses we will compare the occurrence rates of type
II endoleaks and sac growth between historical control and prophylactically
treated patients.
Study design
To obtain evidence needed for a successful CE mark submission, data of
sufficient patients are needed. For this a non-randomized, international,
multi-center safety and performance trial will be set up. However, before
initiating this study we first want to execute a pilot study. In the pilot
study a maximum of 15 patients will be treated in a multiple Dutch medical
centers including AUMC. Aim of the pilot study is to define and evaluate the
feasibility of the clinical procedure of Prophylactic Sac Filling (PSF). The
treatment results of the maximum 15 patients will be reviewed by the DSMB and
used to ask METC approval for the follow-on study.
Intervention
After placement of the EVAR stent graft through openings in both groins, one
additional sheath is inserted through the groin along the stent into the
aneurysm. With the help of x-ray, it is seen whether the sheath has been
inserted in the right place and it is possible to measure how large the
aneurysm is. This measurement is needed to determine how much AneuFix material
is needed to fill the aneurysm. AneuFix is injected through this sheath.
Study burden and risks
The extra burden for the patients who participate in the study is limited to
two extra outpatient clinic visits (screening) compared to the standard follow
up of the patients. In addition, the Aneufix injection is an extra burden as
the standard EVAR procedure will take (about 20 minutes) longer than normal.
The risks associated with participation of the study are related to this
injection procedure, and the correct filling of the aneurysm sac without
off-target embolisation and deformation of the endograft. The polymer itself is
biocompatible, so no risks of presence of Aneufix in the body are expected. The
only disadvantage is the presence of tantalum for visibility during the
injection procedure, which will make the EVAR invisible for future imaging when
necessary.
Urmonderbaan 22
Geleen 6167 RD
NL
Urmonderbaan 22
Geleen 6167 RD
NL
Listed location countries
Age
Inclusion criteria
• Asymptomatic, infrarenal AAA that requires surgery with a high-risk profile
of developing
endoleak type II in line with the recommendations of Fabre et al:
• a patent IMA, with a luminal diameter at its origin > 3 mm, OR
• at least three pairs of patent lumbar arteries, or two pairs of lumbar
arteries and a median
sacral artery or an accessory renal artery.
• Infrarenal neck according to the IFU of the EVAR device
• Other aortic-iliac anatomical configuration suitable for EVAR according to
the criteria of the
EVAR device to be used
• Patient having a life expectation of at least 2 years
• Being older than 18 years
• Willing and able to comply with the requirements of this clinical study
Exclusion criteria
1. Patient not able or willing to give written Informed Consent
2. Patient undergoing emergency procedures
3. Patient undergoing EVAR for ruptured or symptomatic AAA,
4. Patient with a suprarenal AAA
5. Patient with an inflammatory AAA (more than minimal wall thickening)
6. Patient with an infrarenal neck unsuitable for endovascular fixation
(including so called *hostile necks*) or aortic-iliac anatomic configuration
otherwise unsuitable for EVAR according to criteria of the device to be used
7. Patient in which a bilateral retroperitoneal incision is required for EVAR
8. Patient in which a sacrifice of both hypogastric arteries is required
9. Patient with anatomical variations
10. Patient in which the administration of contrast agent is not possible:
proved, severe systemic reaction to contrast agent
11. Patient with active infection present
12. Patients scheduled for or having received an organ transplant
13. Patient with limited life expectation due to other illness (<1 year)
14. Patient with non-iatrogenic bleeding diathesis
15. Patient with connective tissue disease
16. Women of child-bearing potential
17. Patients with evidence at completion angiogram during EVAR of a type Ia or
type III endoleak persistent after balloon inflation.
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 | NCT04307992 |
| CCMO | NL73223.029.20 |