The objective of this study is to assess the safety and effectiveness of the Endologix Nellix® EndoVascular Aneurysm Sealing System for the endovascular repair of infrarenal abdominal aortic aneurysms (AAA). Procedures will be performed per the…
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Source
Brief title
Condition
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
6.1. PRIMARY SAFETY
The safety endpoint is defined as the incidence of Major Adverse Events (MAE)
at 30 days, defined as the composite of the following. Event definitions are
provided in §8.7.7.
* All-Cause Mortality;
* Bowel Ischemia;
* Myocardial Infarction;
* Paraplegia;
* Renal Failure;
* Respiratory Failure;
* Stroke;
* Procedural Blood Loss *1,000mL
6.2. PRIMARY EFFECTIVENESS
The primary effectiveness endpoint is defined as the rate of Treatment Success
at one year. Treatment Success is a composite of outcomes clinically relevant
to the endovascular repair of infrarenal AAA as follows. Event and related
definitions are provided in §8.7.7.
Treatment Success: Procedural technical success and absence of:
* Abdominal aortic aneurysm rupture;
* Conversion to open surgical repair;
* Endoleak Type I or III at 12 months;
* Clinically significant migration;
* Aneurysm enlargement; or
* Secondary endovascular procedure up to 12 months for resolution of
* Endoleak (Type I or Type III)
* Device obstruction or occlusion
* Device migration
* Abdominal aneurysm sac expansion
* Device defect.
Refer to §10.7 for primary effectiveness endpoint analysis details.
Secondary outcome
Additional evaluations include:
* Procedural and In-Hospital Evaluations:
o Volume of contrast media used; o Estimated
blood loss;
o Fluoroscopy time; o %
requiring blood transfusion;
o Total procedure time;
o Anesthesia time;
o Time in ICU; o Time
to hospital discharge;
* Mortality, all-cause and aneurysm-related, within 30 days, at 6 months, and
annually to 5 years;
* MAE Individual Components within 30 days, at 6 months, and annually to 5
years;
* Composite MAEs after 30 days, at 6 months, and annually to 5 years;
* Aneurysm Rupture within 30 days, at 6 months, and annually to 5 years;
* Conversion to Open Surgical Repair within 30 days, at 6 months, and annually
to 5 years;
* Adverse Events (serious and non-serious) within 30 days, at 6 months, and
annually to 5 years;
* Device Performance (aneurysm sac diameter change from the first
post-operative visit; device migration; clinically significant device
migration, incidence of endoleak) at 30 days, 6 months, and annually to 5 years;
* Renal Function pre-discharge and at 30 days, 6 months, and annually to 5
years, as assessed by the estimated glomerular filtration rate (eGFR) and
changes over time;
* Device Patency and Integrity within 30 days, at 6 months, and annually to 5
years, as determined by contrast-enhanced CT scan, and as assessed by the
independent core laboratory, inclusive of:
o Patent luminal
flow o Absence of
kinking or occlusion
o Absence of stent
fracture o Absence of device failure
* Luminal Thrombus Requiring Intervention within 30 days, at 6 months, and
annually to 5 years;
* Secondary Procedure within 30 days, at 6 months, and annually to 5 years for
resolution of endoleak, device occlusion, migration, aneurysm sac expansion
and/or a device defect.
Background summary
Mortality due to AAA rupture ranks 13th in the United States and 10th in Canada
among men older than 65 years. In addition, several authors have suggested an
increase in the mortality rate due to rupture of AAA in the past decades in
both the United Stated and England, with more than 14,000 and 7,259 deaths/year
in those respective countries. Despite being significant, such figures are
probably underestimated, because many deaths resulting from ruptured aneurysms
are not verified by autopsy, and are consequently not documented. Some
researchers have reported that the overall lethality associated with rupture of
AAA approaches 80%, including dead-on-arrival-subjects or those who die before
the diagnosis is made.
AAA is defined clinically as a focal dilatation of the aorta causing a diameter
increase of >50% of the expected normal diameter. Although any artery may
develop an aneurysm, they are most commonly observed in the infrarenal
abdominal aorta, thoracic aorta, popliteal artery and common iliac artery.
The principal risks related to aneurysms are rupture and thrombus migration.
Aneurysms slowly and continually increase in size leading to the aneurysm
rupture. The larger an aneurysm becomes, the likelihood of eventual rupture
increases. The natural history of aortic aneurysms is to enlarge and rupture.
Other potential complications of the aneurysm include compression of adjacent
organs which may result in aortoenteric fistula, or aortocaval fistula. If the
thrombus embolizes and flows down the blood stream, this can induce acute or
chronic arterial obliteration of the lower limbs.
The risk of rupture is weighed against the risk of perioperative morbidity. The
United Kingdom Small Aneurysm trial (UKSAT) reported 103 aneurysm ruptures in
2,257 subjects over a period of seven years, with an annual rupture rate of
2.2%. The decision to treat a patient that presents with an asymptomatic
aneurysm primarily dependents upon the size of the aneurysm. Current Society
for Vascular Surgery (SVS) practice guidelines recommend surveillance for most
subjects with a fusiform AAA in the range of 4.0 to 5.4cm in maximum diameter;
therefore, surgical repair of abdominal aneurysms of 5.5 cm or greater in
diameter is recommended in healthy subjects, as is repair of saccular
aneurysms.
It is estimated that approximately 25% to 40% of infrarenal AAA are not
suitable for endovascular aneurysm repair (EVAR) due to unfavorable proximal
neck anatomy (e.g., highly angulated, dilated, short, or encroaching on or
involving the renal arteries. In most studies of endovascular AAA repair, 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.
When selecting the specific stent graft to be used for EVAR, the
characteristics of the graft must be considered in light of the patient*s
anatomic and physiologic characteristics. Endovascular devices vary in the type
of stent design. For example, most of the currently available devices seal
aneurysms by proximal and distal fixation of the stent graft by either active
fixation (anchoring pins) or oversizing the stent diameter for increased radial
force thereby achieving seal and excluding the aneurysm sac lumen. Greater than
25% of subjects develop an endoleak (mostly type II endoleaks due to
back-bleeding of lumbar or visceral arteries within the aneurysm sac) within
the first two years following endoluminal stent-graft repair, and
approximately 15-20% of the endoleaks persist at five years.8 Endoleaks may
lead to sac enlargement and migration and may require reintervention, using
either catheter-based techniques or conversion to open repair. These secondary
procedures increase the risk to the patient and increase the cost of
treatment. Accordingly, EVAR subjects are routinely monitored annually by
contrast-enhanced CT scan after treatment contributing further to treatment
costs and increasing patient exposure to nephrotoxic contrast agents and
radiation. Recent reports suggest contrast nephrotoxicity affects 7 to 12% of
subjects after CT angiography.
The Nellix System was designed to withstand the migration and lateral
displacement forces acting on endografts, while at the same time excluding the
aneurysm sac lumen and minimizing endoleaks of any kind. The system is
comprised of two independent flow channels, one to each iliac artery. Each flow
channel consists of a balloon-expanded ePTFE covered stent surrounded by a
Polymer-filled EndoBag which fills the blood lumen within the aorta, thus
providing positional stability of the endograft and sealing the aneurysm
completely from side-branch flow. A clinical trial has been performed to
assess the safety and effectiveness of the first generation Nellix system for
endovascular AAA repair and results serve as the basis for CE Mark approval
(October 2012); initial results to one year have been reported. Results of
this trial demonstrate the versatility of the Nellix System in treating a
variety of AAA anatomies, including those that have common iliac artery
involvement bilaterally.
Continued clinical evaluation of the Nellix System in a broader group of
institutions and physicians is therefore appropriate to assess the safety and
effectiveness of the device for AAA repair and the generalizability of the
approach.
Study objective
The objective of this study is to assess the safety and effectiveness of the
Endologix Nellix® EndoVascular Aneurysm Sealing System for the endovascular
repair of infrarenal abdominal aortic aneurysms (AAA). Procedures will be
performed per the Nellix Instructions For Use (IFU) and per institutional
protocols and standard of care for endovascular aneurysm repair. As such, this
study will evaluate the safety and effectiveness of this device system among a
wide range of physicians and in consecutively enrolled subjects to assess
outcomes generalizability.
Study design
This is a multicenter, prospective, single arm clinical study. Subjects with
infrarenal AAA who are suitable candidates for endovascular repair using the
Nellix System, based on protocol Inclusion/Exclusion criteria, will be
considered for enrollment.
After this protocol and the patient informed consent form are reviewed and
approved by the local Ethics Committee/Institutional Review Board (EC/IRB),
patients having infrarenal AAA will be offered participation in the study. This
will be accomplished through the patient*s reading of the informed consent form
in the patient*s native language and discussion of the study with the patient
by the Principal Investigator (PI) and site personnel. Agreement to participate
and to attend all follow-up visits will be documented with the patient*s
signature on the informed consent form, with appropriate signatures.
After providing written informed consent, screening and eligibility
determinations will be performed by the site, Core Lab, Independent Anatomical
Evaluation and Endologix. Subjects will undergo a high resolution,
contrast-enhanced computed tomography angiography (CT) scan of the relevant
aortic and aortoiliac vasculature within three months of the scheduled
procedure(standard of care). Evaluation of the aortic and vascular anatomy
suitability per this protocol, as depicted on the CT scan, will be performed by
the site PI and by an independent core laboratory and will undergo independent
medical evaluation. Other tests include a physical examination, review of
medical history for exclusionary conditions, and selected blood laboratory
analyses. Endologix will notify, in writing, each potential patients final
eligibility status before a case may be scheduled.
Following discharge from the hospital, the first follow-up visit will be made
at 30 days (±2 weeks). A CT scan will be performed to assess aneurysm
morphology and device integrity and patency, as well as the status of the
implanted devices. Subsequent follow-up visits will be made at six months, one
year, and annually to five years per institutional standard of care for
subjects with endovascular stent grafts. Continued subject follow-up beyond
five years is outside of the scope of this study. Nonetheless, all subjects
should be monitored and evaluated per the institutional standards of care for
patients with an implanted endovascular stent graft.
Intervention
Patients with an indication for treatment of their infrarenal abdominal aortic
aneurysm will be treated with the Nellix system according to the instructions
for use.
Study burden and risks
Risks and participation in this study are similar to the usual and current
risks associated with endovascular treatment of infrarenal abdominal aortic
aneuryms. Follow-up will be according to current standard care, except that two
extra CTscans (1 month and 6 months after treatment) will be performed if the
condition of the patient will allow this. (In case of renal failure or
objection by patient or surgeon these will not be performed)
Studebakr 11
Irvine California CA92618
US
Studebakr 11
Irvine California CA92618
US
Listed location countries
Age
Inclusion criteria
*Male or female at least 18 years old;
*Informed consent understood and signed;
*Patient agrees to all follow-up visits;
*Have an infrarenal abdominal aortic aneurysm (AAA) with maximum sac diameter *5.5cm, or an infrarenal AAA * 4.5 cm which has increased by >1.0cm in the past year.
*Anatomic eligibility for the Nellix System per the instructions for use:
oAdequate iliac/femoral access compatible with the required delivery systems (diameter 6 mm);
oAneurysm blood lumen diameter *60mm;
oProximal non-aneurysmal aortic neck:
* length 10mm;
* lumen diameter 16 to 32mm;
* angle 60° to the aneurysm sac;
oMost caudal renal artery to each hypogastric artery length 100mm;
oCommon iliac artery lumen diameter between 8 and 35mm;
oAbility to preserve at least one hypogastric artery.
Exclusion criteria
* Life expectancy <2 years;
* Psychiatric or other condition that may interfere with the study;
* Participating in another clinical study
* Known allergy to device any device component;
* Coagulopathy or uncontrolled bleeding disorder;
* Ruptured, leaking or mycotic aneurysm;
* Serum creatinine level >2.0mg/dL;
* CVA or MI within three months of enrollment/treatment;
* Aneurysmal disease of the descending thoracic aorta;
* Clinically significant infrarenal mural thrombus (>5mm thickness over >50% circumference);
* Connective tissue diseases (e.g., Marfan Syndrome)
* Unsuitable vascular anatomy;
* Pregnant (females 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 |
|---|---|
| Other | Clinicaltrial.gov: NCT01726257 |
| CCMO | NL46684.091.13 |