The primary objective of this study is to assess the feasibility and safety of the Endologix Fenestrated Stent Graft System for the endovascular repair of juxtarenal or pararenal (JAA/PAA) aortic aneurysms in suitable patients. The primary purpose…
ID
Source
Brief title
Condition
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety: Major adverse events at 1 month.
Feasibility: Successful device delivery and deployment with patency of the
renal and aortic endografts without Type I/III endoleak at 1 month.
Procedural, clinical, and assisted clinical feasibility will be reported.
Secondary outcome
Additional evaluations include:
* Procedural and in-hospital evaluations: Anesthesia time; fluoroscopy time;
contrast volume used; total procedure time; estimated blood loss; % of patients
with transfusion; time in ICU; time to hospital discharge.
* Death (all-cause and aneurysm-related) within 30 days, at 6 months, and
annually at 1 to 5 years;
* Major adverse events after 30 days, at 6 months, and annually at 1 to 5 years;
* Individual major adverse event components within 30 days, at 6 months, and
annually at 1 to 5 years;
* Aneurysm rupture within 30 days, at 6 months, and annually at 1 to 5 years;
* Conversion to open repair within 30 days, at 6 months, and annually at 1 to 5
years;
* Adverse Events: All serious and non-serious events within 30 days, at 6
months, and annually at 1 to 5 years;
* Distal blood flow (ankle-brachial index evaluations) pre-discharge and at 30
days, 6 months, and annually at 1 to 5 years;
* Endograft performance (aneurysm sac diameter changes; device migration;
incidence of endoleak) at 30 days, 6 months, and annually at 1 to 5 years;
* Renal function as assessed by estimated glomerular filtration rate (eGFR)
pre-discharge and at 30 days, 6 months, and annually at 1 to 5 years;
* Renal stent graft patency and integrity at 30 days, 6 months, and annually at
1 to 5 years;
* Stent graft (fenestrated/bifurcated) patency and integrity at 30 days, 6
months, and annually at 1 to 5 years;
* Secondary procedures within 30 days, at six months, and at years 1through 5
for resolution of endoleak, limb occlusion, migration, aneurysm
sac expansion and/or a device defect.
Background summary
An extensive summary of current scientific literature regarding surgical and
endovascular techniques and devices used in the repair of JAA or PAA is
provided in the Clinical Investigator*s Brochure (CIB). A brief summary is
provided below: An arterial aneurysm is a permanent, localized dilatation of an
artery with an increase in diameter of 50% or more than the normal artery
diameter. Although any artery may develop an aneurysm, most commonly an
aneurysm is seen in the abdominal aorta, thoracic aorta, popliteal artery or
common iliac artery. Abdominal aortic aneurysm (AAA) is a progressive disease
characterized by structural deterioration, gradual expansion, and eventual
rupture of the abdominal aorta if left untreated. AAA is the most common type
of aortic aneurysm, with more than 90% occurring inferior to the renal
arteries. This vascular disorder causes significant mortality and morbidity in
the aged population and is a leading cause of death. The complexity of AAA is
commonly characterized based on location and involvement with visceral vessels.
Infrarenal AAA generally involves the infrarenal aorta and may involve the
aortoiliac vasculature. A subset of infrarenal AAA extends up to the level of
but does not involve the renal arteries, and is termed juxtarenal AAA (JAA). A
small proportion of AAA involves the renal arteries and as such is termed
pararenal AAA (PAA). Extension of the disease to and beyond the superior
mesenteric artery (SMA) or celiac artery (CA) into the thoracic aorta describes
thoracoabdominal aneurysms. These more complex aneurysms are beyond the scope
of this study. It is estimated that approximately 25% to 40% of infrarenal AAA
are not suitable for endovascular repair due to unfavorable proximal neck
anatomy (e.g., highly angulated, dilated, short [JAA], or encroaching on or
involving the renal arteries [JAA or PAA]).In most US studies of endovascular
AAA repair, including that for the Endologix Powerlink System, the infrarenal
non-aneurysmal neck length and angulation to the aneurysm sac requirements are
*15mm and *60°, respectively; shorter lengths or greater angulation have been
reported to increase the risk of migration and Type 1A endoleak and associated
need for intervention.Owing to the increased risk of renal complications,
mesenteric ischemia and other complications following open repair of JAA or PAA
compared to infrarenal AAA or hybrid open visceral debranching techniques,
researchers have sought to extend a totally endovascular technique to repair of
these aneurysms. To consider application of an endovascular method to JAA or
PAA repair, it is essential to maintain the patency of visceral vessels (i.e.,
renal arteries; SMA; CA). Browne and colleagues reported their feasibility
experience in the construction and implant of home made
fenestrated stent grafts using Dacron graft and stainless steel Z-stents in the
canine model. Each fenestration was sized to approximate the size of the
arterial ostium, an improvement over prior reports suggesting that oversizing
of the fenestration may be necessary to ensure the ostia are not covered. Six
hours after implant, animals were sacrificed and the positioning of all
fenestrations verified. No ostial obstruction was observed, and the devices
were widely patent. Several single center clinical case reports have described
the use of *homemade* fenestrated stent grafts fashioned by physicians from
commercially available stent grafts for the endovascular repair of JAA/PAA.
Although cited as technically feasible in some patients, the broad application
of this approach does not appear to be generally accepted by the medical
community. A number of single center and several multicenter reports of a
custom device based on the Cook Zenith stent graft are available in the
literature. The key limitation to this approach is the need to customize the
design and manufacture of each stent graft to a particular patient anatomy.
This requires a lengthy period of time for planning, manufacture, and delivery
of the device. More recently, several publications attempt to propose methods
for modifying this customization algorithm broaden the applicability of a
particular device to more than one patient. That is, to create an *off-
theshelf* fenestrated stent graft device. Endologix, Inc. has developed a Stent
Graft System based on the approved Powerlink design that is specifically
intended as a potential *off-the-shelf* endovascular repair option for JAA/PAA.
This design couples the CE Marked and U.S. FDA-approved Powerlink bifurcated
stent graft with a fenestrated/scalloped proximal extension and renal stent
grafts with the intent to be applicable to approximately 80-90% of patients
presenting with JAA/PAA.
Study objective
The primary objective of this study is to assess the feasibility and safety of
the Endologix Fenestrated Stent Graft System for the endovascular repair of
juxtarenal or pararenal (JAA/PAA) aortic aneurysms in suitable patients. The
primary purpose of this study is to support CE Mark approval for the Endologix
fenestrated proximal extension and renal stent graft devices.
Study design
This is multicenter, prospective, single arm clinical feasibility/safety study.
Intervention
Endologix Fenestrated JAA/PAA proximal extension stent graft devices
Endologix renal stent graft devices
Study burden and risks
The decision to repair an aortic aneurysm is generally based on the risk of
rupture, the risk of complications of surgery, and patient preference. There
are currently two methods used to repair aortic aneurysms. The most common and
conventional method is an open surgical repair, with the implantation of a
synthetic graft to replace the diseased aneurysmal vessel through a large
abdominal incision. Recent technological developments have resulted in an
alternative, minimally invasive, endovascular aneurysm repair, in which a stent
graft is placed within the aorta through a small incision in the groin. Blood
can then flow through the stent graft and is excluded from the aneurysmal
portion of the aorta.
The disadvantages of open surgical repair are: general anesthesia is required,
it is a major abdominal surgery (large incision), has a significant surgical
complication rate, and typically requires a long hospital stay and recovery.
EVAR enables local or regional anesthesia to be used, uses a minimally invasive
groin incision for catheter-based access, and has been reported in US clinical
studys to offer a lower operative
complication rate, reduced blood loss and procedure times, and shorter hospital
stay. In contrast to open repair, EVAR is a relatively new treatment, long term
results have not been fully established, and life long surveillance is
recommended to verify stent graft integrity and patency and continued aneurysm
exclusion. Currently, five device systems are FDA-approved and marketed in the
US for endovascular abdominal aortic aneurysm repair. All of these devices
require the introduction of catheter-based treatment devices varying in outer
diameter profile from 20Fr to 25Fr (ipsilateral). Standard vascular exposure is
indicated for access. Prospective clinical study results support the safety and
effectiveness of
these stent grafts through early follow-up (to 30 days) and in late follow-up
to one year and to up to five years. These and other devices are CE Marked and
are available in other international regions. One custom device is CE Marked
for JAA endovascular repair; however, no *off-the-shelf* endovascular devices
are currently commercially available.
As with any procedure there are risks of serious complications, such as death.
The inclusion and exclusion criteria for this population have been carefully
established to limit the risk of mortality and morbidity in this population.
The overall risk will be evaluated on an individual basis and discussed with
each patient. All of the potential adverse events outlined previously could
cause prolonged illness, permanent impairment of daily function or, in rare
cases, death. Possible treatments could include, but are not limited to,
emergency cardiac or vascular surgery.
Eligibility criteria that exclude patients who are at higher risk for
experiencing an anticipated adverse event have been selected to reduce the
potential risks to patients who participate in this study. In addition, the
assessment of patient anatomy for enrollment by an experienced Core Laboratory
is also intended to reduce the potential risks to patients who participate in
this study.
Pre-procedural high resolution, contrast-enhanced CT scanning and
intraprocedural arteriography will be used to identify and target the aortic
anatomy to facilitate the proper introduction, delivery, and deployment of the
endovascular repair devices. Physician experience, rigorous application of a
common protocol, and careful performance of the procedure with close monitoring
of the patient after the procedure will also help to minimize risks.
Alternatives to endovascular repair of JAA/PAA include open surgical repair.
11 Studebaker
Irvine CA 92618
US
11 Studebaker
Irvine CA 92618
US
Listed location countries
Age
Inclusion criteria
Male or female at least 18 years old; informed consent understood and signed and patient agrees to all follow-up visits; have aortic aneurysm with maximum diameter *5.5cm, or between 4.5 and 5.5cm and rapidly expanding (>0.5cm in six months), or >50% larger than normal aortic diameter. Anatomically eligible for the Endologix Bifurcated System per the FDAapproved indications for use (IFU) and for the Fenestrated Stent Graft System.
Exclusion criteria
Life expectancy <2 years as judged by the investigator; Psychiatric or other condition that may interfere with the study; Participating in the enrollment or 30-day follow-up phase of another clinical study; Known allergy to any device component; Coagulopathy or uncontrolled bleeding disorder; Contraindication to contrast media or anticoagulants; Ruptured, leaking, or mycotic aneurysm; Aortic dissection Serum creatinine (S-Cr) level >2.0 mg/dL;Traumatic vascular injury; Active systemic or localized groin infection; Connective tissue disease (e.g., Marfan*s Syndrome);
Recent (within prior three months) cerebrovascular accident or myocardial infarction; Prior renal transplant; Length of either renal artery to be stented <12mm; Significant occlusive disease of either renal artery (>70%); An essential accessory renal artery; Indispensable inferior mesenteric artery; Untreated aneurysmal disease of the descending thoracic aorta; Prior iliac artery stent implanted that may interfere with delivery system introduction; Unsuitable vascular anatomy; Pregnancy (female patient of childbearing potential only).
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 |
|---|---|
| CCMO | NL39259.091.11 |