Monocenter Feasibility Study using the fenestrated ANACONDA endograft for juxta- and suprarenal abdominal aorta aneurysm repair

Abdominal aortic aneurysm is conventionally repaired by open surgery using a
prosthetic graft. This method of repair involves laparotomy and cross-clamping
of the aorta and has a mortality rate of 5 % (Zarins et al, 1997, EVAR 1, 2005;
EVAR 2 ,2005; DREAM, 2005). In addition the procedure is associated with a
complication rate of 15-37% including significant blood loss, infection and a
prolonged anaesthetic time. (White et al, 1996). Endovascular aneurysm repair
offers potential benefits including reduced operative time, reduced blood loss,
decreased post-operative intensive care (Politz et al 2000) and increased 4
years survival compared to open repair (EVAR 1). This is especially the case in
relatively healthy patients (EVAR 1, 2005 and EVAR 2, 2005). All these studies
only studies endovascular repair in infrarenal AAA.

Since the first report of a juxtarenal abdominal aortic aneurysm (AAA)
endovascularly treated with a fenestrated stent graft in 1999,1 a number of
published series have demonstrated excellent early and mid-term results of the
technique (Greenberg 2004, Ziegler 2007, Verhoeven 2010). A recently published
systematic review confirms the potential lower perioperative mortality of the
technique in comparison with open repair (nordon 2009). Fenestrated stent
grafts are now commercially available and provide an alternative to open
surgery, especially in patients who are at increased risk for open repair.

To test the feasibility of the ANACONDA endograft for the endovascular repair
of juxta and suprarenal AAA.

Prospective feasibility study in approximately 20 patients
Inclusion period of 2-4 years (in order to include at least 20 patients)
Follow-up as current standard for AAA (life long) with analysis at 2 and 4
years of follow-up (not including the interim analysis; see protocol)

ANACONDA fenestrated endograft.

The operation will be performed under local, epidural or general anaesthetic in
the operating theatre at the discretion of the surgeon based on individual
patient status. The patient will be positioned and prepared as for conventional
open surgery. All the implants will be performed by a team of vascular surgeons
and interventional radiologists with an EVAR experience of at least 100
implants and supervised by vascular surgeons or interventional radiologist
(proctor) with a comparable EVAR experience including at least 10 ANACONDA
endografts.

The procedure will require surgical exposure of the Femoral Arteries or Common
Iliac Arteries and will be performed by surgical cut down and formation of an
arteriotomy. During the procedure intravenous Heparin 5,000 IU or 100 IU
heparin/kg bodyweight will be required for anti-coagulation therapy in
accordance with standard endovascular procedures.

Digital subtraction angiography device will be used throughout the operation.
A final contrast enhanced high pressure Aortogram will be performed to assess
success of aneurysm exclusion.

The surgical technique must be carried out in accordance with the Vascutek
Limited instructions for use.

Burden and risks are as follows: no exclusion of the aneurysm wich may need
extra endovascular treatment during the primary intervention or during
follow-up. Conversion to open repair if endovascular repair is not possible
whcih may lead to the known risks of open repair. The presence of an endograft
does not mean per se that the open rapair will be more difficult or hazardous.
During stenting of the renal or meseteric arteries, damage may occur to these
vessels which may need further treatment, usually endovascular. This may lead
to a deterioration in kidney function. The risk for other complications, i.e.
cardiac and infections, is lower compared to the open procedure.