The primary (performance) objective of the study is to assess the feasibility to treat repair type II endoleaks with ANEUFIX successfully, which is called *technical success*.The secondary objective of the study is to assess the clinical success…
ID
Source
Brief title
Condition
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary end-point is defined as *Technical success of Type II endoleak repair
with ANEUFIX as demonstrated by the absence of endoleak circulation at the
intended treated endoleak at the end of the procedure*. The presence or
absence of the endoleak treated with Aneufix is verified by means of a CT scan
the next day.
Secondary outcome
The secondary end-points are defined as:
- Absence of aneurysm sac growth at 6, 12 and 24 months (determination of
clinical success rate via CT scans). Growth is determined based on independent
imaging core lab assessments of the abdominal aortic diameter, measured as the
maximum diameter relative to the aneurysm;
- Documentation of intra- and peri-operative complications (<30 days);
- Occurrence of serious adverse events, vascular related adverse events and
adverse device effects: complications and deaths, re-interventions, aneurysm
rupture in the peri operative period.
- Occurrence of general adverse events and adverse device effects at 1 week,
and 1 month, 6, 12 and 24 months;
- Rate of secondary endovascular or surgical re-interventions at 1, 6, 12 and
24 months;
- Rate of aneurysm rupture at 6, 12 and 24months;
- Survival throughout the study up until 24 months.
Safety is assessed based on the nature and severity of adverse events.
The secondary end-point of aneurysm sac growth will be assessed by means of
CT-scan at the 6, 12 and 24 month follow up, and be based upon the measurement
of the diameter of the AAA-sac. It is anticipated that no AAA-sac growth will
be observed in minimally 80% of those patients where the procedure is
successfully executed. The AAA sac growth will be re-assessed by an independent
core lab. All other safety related adverse events are documented and
adjudicated by the DSMB.
Background summary
Endovascular aortic aneurysm repair (EVAR) has become a well-established
treatment modality for infrarenal abdominal aortic aneurysms (AAA) repair.
EVAR, however, might be associated with some complications. Complications and
re-interventions caused by endoleaks, stent-graft migration, or device failure
(in general) are of major concern. As a result, lifelong imaging follow-up is
needed since these complications can be associated with late aneurysm rupture.
The major complication with EVAR is the potential occurrence (early or late) of
endoleaks. Different types of endoleaks are described with different incidences
and different levels of impact. A recent article (Mees et al. 2013) list
current endoleak type II treatments, incidences, clinical outcomes. The article
concludes that few endoleaks of this type II require treatment in view of the
relative low clinical success rates, the high morbity and even high mortality
rates of some (surgical) interventions: a conservative management is advised,
definitely when no aneurysm sac growth is observed.
Despite the high incidence of endoleak type II (in about 30% of EVAR-patients),
even associated with the occurrence of aneurysm sac growth (in about 6% of
EVAR-patients), the treatment success of type II endoleaks are disappointing.
Conclusions of literature review:
1. Type II Endoleaks are frequently occuring post-EVAR; but frequently resolve
spontaneously in case of early type II endoleaks < 6 months
2. 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;
3. The technical success rates are typically high: >80%
4. The clinical success rates (sac growth stabilization or decrease) over more
than 1 year are typically low: <60%;
5. None of the current treatment techniques offers the ultimate good
solutionclinical success;
tion techniques are more and more used also for Type I Endoleak treatments
whereby larger volumes of up to 20 ml are used to create the cast.
The current study aimes to come to a succesfull, safe and technical feasible
treatment of endoleaks type II and to open the way for research of the
treatment of endoleaks type I.
Study objective
The primary (performance) objective of the study is to assess the feasibility
to treat repair type II endoleaks with ANEUFIX successfully, which is called
*technical success*.
The secondary objective of the study is to assess the clinical success rate
(clinical benefit objective) and to observe, document and handle occurring
complications well (safety objective).
Study design
The study is a non-randomized, international, multi-center safety and
performance trial. Aneufix is applied in 57 patients suffering from endoleak
type II requiring an intervention.Clinical benefit of the ANEUFIX procedure is
demonstrated by the absence of aneurysm sac growth and thus the reduced risk
for death.
Intervention
The aneurysm sac is punctured via a trans-lumbar approach under CT-guidance. A
large bore introduction sheath (minimal 4 Fr) is positioned. Aneufix is
injected under fluoroscopic control to fill the endoleak void, including the
nidus of the artery causing the leak and of the relevant draining artery.
Study burden and risks
The extra burden for the patients who participate in the study is limited to
two extra outpatient clinic visits (screening, baseline) compared to the
standard follow up of the patients. In addition, the procedure where Aneufix is
injected is an extra burden. This will be performed via translumbar injection
under CT guidance. The risks associated with participation of the study are
related to this injection procedure. 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 fo 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
1. Persistent type II endoleak (more than 6 months post-EVAR or
post-embolization procedure); AND
2. Volume of the 'endoleak void' can be estimated upfront; AND
3. An endoleak confirmed on a CT scan that should be done within 180 days prior
to procedure but preferably within 90 days prior to screening demonstrating the
high likelihood of the isolated nature of the endoleak; AND
4. An aneurysm sac growing after EVAR of minimal 10 mm (per European
Guidelines) as documented in the preceding 90 days by means of CT-imaging
(alternative imaging technique) and based upon sac diameter measurements; AND
5. An aneurysm sac that can be punctured in translumbar approach; AND
6. Possibility to withhold anti-thrombogenic medication temporarily; AND
7. Ability and willingness to undergo the translumbar procedure; AND
8. Be older than 18 years.
Exclusion criteria
1. Patient not able or willing to give written Informed Consent themselves; OR
2. Patient undergoing emergency procedures; OR
3. Patient with traumatic vascular injury; OR
4. Patient with an untreated endoleak connected to an open AMI (patients
can be included if the AMI is coiled or is technically not possible to be
coiled prior the Aneufix application); OR
5. Patient with hemostatic disorder (including bleeding disorders) or who is
clinically unstable; OR
6. Patient with a too high risk of abdominal sac rupture to allow safe
radiological and scanographic assessments; OR
7. Patient who is allergic to contrast media or anticoagulants; OR
8. Patient with renal impairment (eGRF < 30 ml/min); OR
9. Patient with a contra-indication for temporal positioning of a translumbar
needle/catheter; OR
10. Patient who is participating in another trial with an investigational drug
or medical device or where a medical device/drug is used outside its labelling
and its approved intended use; OR
11. Pre-menopausal women, OR
12. Patient with a life expectancy of less than 12 months; OR
13. Patient with an intra aneurysm systolic blood pressure > 125 mmHg
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 |
|---|---|
| Other | NCT03918460 |
| CCMO | NL69807.029.19 |