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

Abdominal Aortic Aneurysm (AAA) Clinical Trial

— EVAS IDE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01726257
• Other study ID #: CP-0008
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: December 2022

Study information

• Verified date: February 2023
• Source: Endologix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 333
• Est. completion date: December 2022
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm (AAA)
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• Nellix System
Subjects in this study will receive a Nellix Endovascular Sealing System as part of their intervention.

Locations

Country	Name	City	State
Germany	University of Heidelberg	Heidelberg	Baden-Württemberg
Netherlands	Rijnstate Hospital	Arnhem
United Kingdom	Addenbrooke's Hospital	Cambridge
United States	St. Vincent Heart and Vascular Center of Montana	Billings	Montana
United States	St. Elizabeth's Medical Center	Brighton	Massachusetts
United States	Cooper Hospital	Camden	New Jersey
United States	Carolinas Health Care	Charlotte	North Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	Ohio Health Research Institute	Columbus	Ohio
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Spectrum Health	Grand Rapids	Michigan
United States	St. Luke's Medical Center	Houston	Texas
United States	St. Vincent Heart Center of Indiana	Indianapolis	Indiana
United States	Nebraska Heart Institute	Lincoln	Nebraska
United States	Baptist Hospital of Miami	Miami	Florida
United States	Froedtert Memorial Lutheran Hospital (Medical College of Wisconsin)	Milwaukee	Wisconsin
United States	Minneapolis Hospital	Minneapolis	Minnesota
United States	Yale University	New Haven	Connecticut
United States	Christiana Care Hospital	Newark	Delaware
United States	Sacred Heart	Pensacola	Florida
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	UPMC Heart and Vascular Institue	Pittsburgh	Pennsylvania
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	Maine Medical Center	Portland	Maine
United States	VA San Diego	San Diego	California
United States	Providence Sacred Heart Medical Center	Spokane	Washington
United States	Bay State Hospital	Springfield	Massachusetts
United States	Scott & White Healthcare System	Temple	Texas
United States	Tucson Medical Center	Tucson	Arizona
United States	MedStar Health Research Institute	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Endologix

Countries where clinical trial is conducted

United States,  Germany,  Netherlands,  United Kingdom, 

References & Publications (2)

Kisis K, Krievins D, Naskovica K, Gedins M, Savlovskis J, Ezite N, Lietuvietis E, Zarins K. Quality of life after endovascular abdominal aortic aneurysm repair: nellix sac-anchoring endoprosthesis versus open surgery. Medicina (Kaunas). 2012;48(6):286-91. — View Citation

Krievins DK, Holden A, Savlovskis J, Calderas C, Donayre CE, Moll FL, Katzen B, Zarins CK. EVAR using the Nellix Sac-anchoring endoprosthesis: treatment of favourable and adverse anatomy. Eur J Vasc Endovasc Surg. 2011 Jul;42(1):38-46. doi: 10.1016/j.ejvs.2011.03.007. Epub 2011 Apr 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Events at 30 Days	Major Adverse Events = all-cause death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, and blood loss >1,000cc	30 days
Primary	Treatment Success at 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.	1 year
Secondary	Major Adverse Events From 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	>30 days to 5 years
Secondary	Clinical Utility Outcomes	anesthesia time; fluoroscopy time; contrast volume; estimated blood loss; % requiring transfusion; procedure time	At the time of procedure
Secondary	Time in ICU	Number of hours spent in the intensive care unit (ICU)	Up to 7 days
Secondary	Adverse Events	All serious and non-serious events within 30 days, at 6 months, and at 1 to 5 years	> 30 days to 5 years
Secondary	Aneurysm Rupture		> 30 days to 5 years
Secondary	Conversion to Open-Surgical Repair		>30 days to 5 years
Secondary	Device Performance	aneurysm sac diameter change from the first post-operative CT scan, device migration, device patency, device integrity, incidence of endoleak	> 30 days to 5 years
Secondary	Mortality		> 30 days to 5 years
Secondary	Renal Dysfunction	assessment of estimated glomerular filtration rate (eGFR)	Post-procedure to 5 years
Secondary	Secondary Surgical Intervention	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.	Post-procedure to 5 years
Secondary	Time to Hospital Discharge	Number of days spent in hospital	Up to 7 days