The primary objective of the study is to assess the feasibility to treat type II endoleaks with Aneufix ACP-T5 successfully.The secondary objectives of the study are to assess the:- Clinical success rate defined as Occurrence of adverse events and…
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 ACP-T5 as demonstrated by the absence of an endoleak at the end of
the procedure*.
Secondary outcome
The secondary end-points are defined as:
- Occurrence of general adverse events and adverse device effects at 1, 3, 6
and 12 months and 24 months;
- Absence of aneurysm sac growth at 6 and12 months (clinical success rate);
- Rate of peri-operative complications (<30 days);
- Rate of secondary endovascular or surgical re-interventions at 1, 3, 6 and 12
months;
- Rate of aneurysm rupture at 6 and 12months;
- Survival throughout the study
Safety is assessed based on the nature and severity of adverse events.
Background summary
Endovascular aortic aneurysm repair (EVAR) has become a well-established
treatment modality for abdominal (infra-renal artery ) aortic aneurysms (AAA)
repair. EVAR, however, has several disadvantages. Complications and
re-interventions caused mainly by endoleaks, endotension, stent-graft
migration, and device failure are of major concern. As a result, lifelong
follow-up is needed since these complications can be associated with aneurysm
rupture. In addition, EVAR has anatomical restrictions.
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, Voute, Bastos Gonçalves, Mota Capitao, & Verhagen,
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 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
and rather in the order of about 25% (Schanzer, et al., 2011) and rarely
correctly and fully successfully addressed: freedom from sac growth after
repair is the only relevant successful outcome measure (Mees, Voute, Bastos
Gonçalves, Mota Capitao, & Verhagen, 2013).
Conclusions of literature review:
1. Type II Endoleaks are frequently occuring post-EVAR. Conservative treatment,
i.e. surveillance follow up, seems most appropriate as the risk for sac rupture
is low.
2. However, in situations where the aneurysm sac is growing as a result of the
presence of Type II Endoleaks, reinterventions are attempted to treat the
endoleak with a variety of transarterial or translumbar methods.
3. The typical large variety of methods and techniques applied within a single
center (coil, glue, plug,..) is indicative that none of the current techniques
offers the ultimate good solution.
4. As reinterventions to treat a Type II Endoleak are expensive (in the order
of $40,000 - Jouhannet, et al., 2014), the prevention of it will remain a
desire and an ongoing challenge till a simple technique with high success rate
and low complication rates becomes available.
5. A reintervention aims also for a long-term effective repair; today the
success rates are too low and the purchase costs too high to make the use of
embolisation glue (Onyx, Squid) widely and generally applicable, except for its
initial intended use.
6. Recently, the same embolization 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 objective of the study is to assess the feasibility to treat type
II endoleaks with Aneufix ACP-T5 successfully.
The secondary objectives of the study are to assess the:
- Clinical success rate defined as
Occurrence of adverse events and adverse device effects: complications and
deaths, re-interventions, aneurysm ruptures
Study design
The study is a non-randomized, multi-center safety and feasibility trial.
Aneufix ACP-T5 is applied in 5 patients suffering from endoleak type II
requiring an intervention.
An independent Data Safety Monitoring Board (DSMB) will review the clinical
outcome data and decide on the safety of the procedure for each individual
enrolled patient. The decision of the DSMB is based on the assessment of
severity of intra- and peri-operative (adverse device) effects. A positive
outcome of the DSMB meeting is required to continue to enrol the next patient.
A one month follow up period for the first patient and a one week follow up
period for the other patients is considered for the decision making on the
study continuation by the DSMB.
Intervention
The aneurysm sac is punctured via a trans-lumbar approach under CT-guidance by
interventional radiologist. Through a 5-7Fr introduction sheath0 a filling and
a draining catheter are positioned. ACP-T5 is injected under fluoroscopic
control to completely fill the endoleak void, including the nidus of the artery
causing the leak.
Study burden and risks
The extra burden for the patients who participate in the study is limited to
three extra outpatient clinic visits (screening, baseline and 1 month follow
up) compared to the standard follow up of the patients. In addition, the
procedure where Aneufix ACP-T5 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 ACP-T5 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.
Oxfordlaan 55
Maastricht 6229 EV
NL
Oxfordlaan 55
Maastricht 6229 EV
NL
Listed location countries
Age
Inclusion criteria
- Persistent type IIa or IIb endoleak (more than 6 months post-EVAR or post-embolization procedure); AND
- Volume of the *endoleak void* can be determined upfront; AND
- An EVAR without circulatory complications; AND
- An endoleak confirmed by CT scan in preceding 8 weeks demonstrating the high likelihood of the isolated nature of the endoleak; AND
- An aneurysm sac either growing in contours after EVAR (per European Guidelines) as documented in the preceding 8 weeks by means of echo (or alternative visualization technique); AND
- An aneurysm sac that can be punctured in translumbar approach from minimally two directions; ANDPossibility to withhold anti-thrombogenic medication temporarily; AND
- Ability and willingness to undergo the translumbar procedure under local anesthesia in a CT scan
-Patients older than 18 years
Exclusion criteria
- Patient not able or willing to give written Informed Consent; OR
- Patient undergoing emergency procedures; OR
- Patient with traumatic vascular injury; OR
- Patient with hemostatic disorder or who is clinically unstable; OR
- Patient with a risk of abdominal sac rupture too high to allow safe radiological and scanographic assessments; OR
- Patient who is allergic to contrast media or anticoagulants; OR
- Patient with renal impairment (serum creatinine > 2 mg/dl or > 176 mmol/l); OR
- Patient who is participating in another trial with an investigational drug or medical device; OR
- Patient with a life expectancy of less than 12 months.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
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 | NCT02487290 |
| CCMO | NL53866.098.15 |