EVAS IDE: Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System

Sponsor

Endologix (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT01726257

Collaborator

(none)

333

Enrollment

Locations

Arm

102

Anticipated Duration (Months)

11.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to assess the safety and effectiveness of the Endologix Nellix® System for the endovascular repair of infrarenal abdominal aortic aneurysms (AAA).

Condition or Disease	Intervention/Treatment	Phase
Abdominal Aortic Aneurysm (AAA)	Device: Nellix System	N/A

Detailed Description

This study will evaluate the safety and effectiveness of the Nellix System among a wide range of physicians and in consecutively enrolled subjects to assess outcomes generalizability. Following appropriate government and ethics committee/IRB approval the Nellix® EndoVascular Sealing System will be implanted into eligible patients who are adequately informed and have consented to join the study. Enrolled patients 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 and at specified follow-up intervals post-implantation. Follow-up visits will occur at 30 days, 6 months, and annually to 5 years to assess aneurysm morphology, the status of the implanted devices, and relevant laboratory test results.

Study Design

Study Type:

Interventional

Actual Enrollment :

333 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Prospective, Multicenter, Single Arm Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System: A Pivotal and Continued Access Study

Actual Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Jun 1, 2016

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nellix System Nellix Endovascular Aneurysm Sealing System is the only arm for this study. This is a single arm study.	Device: Nellix System Nellix Endovascular Aneurysm Sealing System is the only arm for this study. This is a single arm study.

Arm

Intervention/Treatment

Experimental: Nellix System

Nellix Endovascular Aneurysm Sealing System is the only arm for this study. This is a single arm study.

Device: Nellix System

Nellix Endovascular Aneurysm Sealing System is the only arm for this study. This is a single arm study.

Outcome Measures

Primary Outcome Measures

Major Adverse Events at 30 Days [30 days]
Major Adverse Events = all-cause death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, and blood loss >1,000cc
Treatment Success at 1 Year [1 year]
Treatment Success = procedural technical success and the absence of aneurysm rupture, conversion to open surgical repair, Type I endoleak at 12 months, Type III endoleak at 12 months, aneurysm enlargement, secondary procedure for resolution of endoleak (Type I or III), limb occlusion, migration, aneurysm sac expansion and/or a device defect.

Secondary Outcome Measures

Major Adverse Events From 30 days to 5 years [>30 days to 5 years]
Major Adverse Events = all-cause death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, and blood loss >1,000cc
Clinical Utility Outcomes [At the time of procedure]
anesthesia time; fluoroscopy time; contrast volume; estimated blood loss; % requiring transfusion; procedure time
Time in ICU [Up to 7 days]
Number of hours spent in the intensive care unit (ICU)
Adverse Events [> 30 days to 5 years]
All serious and non-serious events within 30 days, at 6 months, and at 1 to 5 years
Aneurysm Rupture [> 30 days to 5 years]
Conversion to Open-Surgical Repair [>30 days to 5 years]
Device Performance [> 30 days to 5 years]
aneurysm sac diameter change from the first post-operative CT scan, device migration, device patency, device integrity, incidence of endoleak
Mortality [> 30 days to 5 years]
Renal Dysfunction [Post-procedure to 5 years]
assessment of estimated glomerular filtration rate (eGFR)
Secondary Surgical Intervention [Post-procedure to 5 years]
The number of additional surgical procedures to repair resolution of endoleak, limb occlusion, migration, aneurysm sac expansion and/or a device defects will be collected.
Time to Hospital Discharge [Up to 7 days]
Number of days spent in hospital

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female at least 18 years old;
Informed consent understood and signed;
Patient agrees to all follow-up visits;
Have AAA with sac diameter ≥5.0cm, or ≥4.5 cm which has increased by >1.0cm in the past year.
Anatomic eligibility for the Nellix System per the instructions for use:
Adequate iliac/femoral access compatible with the required delivery systems (diameter ≥6 mm);
Aneurysm blood lumen diameter ≤60mm;
Most caudal renal artery to aortoiliac bifurcation length ≥100mm;
Proximal non-aneurysmal aortic neck: length ≥10mm; lumen diameter 18 to 32mm; angle ≤60° to the aneurysm sac;
Common iliac artery lumen diameter between 9 and 35mm with blood lumen diameter ≤35mm;
Ability 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 enrollment of 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tucson Medical Center	Tucson	Arizona	United States	85712
2	VA San Diego	San Diego	California	United States	92161
3	Yale University	New Haven	Connecticut	United States	06437
4	Christiana Care Hospital	Newark	Delaware	United States	19713
5	MedStar Health Research Institute	Washington	District of Columbia	United States	20010
6	Baptist Hospital of Miami	Miami	Florida	United States	33176
7	Sacred Heart	Pensacola	Florida	United States	32504
8	St. Vincent Heart Center of Indiana	Indianapolis	Indiana	United States	46077
9	Maine Medical Center	Portland	Maine	United States	04102
10	St. Elizabeth's Medical Center	Brighton	Massachusetts	United States	02135
11	Bay State Hospital	Springfield	Massachusetts	United States	01199
12	Spectrum Health	Grand Rapids	Michigan	United States	49546
13	Minneapolis Hospital	Minneapolis	Minnesota	United States	55407
14	St. Vincent Heart and Vascular Center of Montana	Billings	Montana	United States	59101
15	Nebraska Heart Institute	Lincoln	Nebraska	United States	68526
16	Cooper Hospital	Camden	New Jersey	United States	08102
17	Carolinas Health Care	Charlotte	North Carolina	United States	28203
18	Cleveland Clinic	Cleveland	Ohio	United States	44195
19	Ohio Health Research Institute	Columbus	Ohio	United States	43214
20	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
21	UPMC Heart and Vascular Institue	Pittsburgh	Pennsylvania	United States	15232
22	St. Luke's Medical Center	Houston	Texas	United States	77030
23	The Heart Hospital Baylor Plano	Plano	Texas	United States	75093
24	Scott & White Healthcare System	Temple	Texas	United States	76508
25	Inova Fairfax Hospital	Falls Church	Virginia	United States	22042
26	Providence Sacred Heart Medical Center	Spokane	Washington	United States	99204
27	Froedtert Memorial Lutheran Hospital (Medical College of Wisconsin)	Milwaukee	Wisconsin	United States	53226
28	University of Heidelberg	Heidelberg	Baden-Württemberg	Germany	D-69120
29	Rijnstate Hospital	Arnhem		Netherlands	90
30	Addenbrooke's Hospital	Cambridge		United Kingdom	CB2 0QQ