Clinical trial NCT01726257: Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysm (AAA)
Keywords: Infrarenal
Abdominal
Aortic
Aneurysm
AAA
Endologix
EVAS
EndoVascular
Sealing
System
Lead sponsor: Endologix
Sponsor class: INDUSTRY
First posted: 2012-11-14
Enrollment: 333
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Major Adverse Events at 30 Days
timeFrame: 30 days
measure: Treatment Success at 1 Year
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Tucson Medical Center
state: Arizona
city: San Diego
country: United States
facility: VA San Diego
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Newark
country: United States
facility: Christiana Care Hospital
state: Delaware
city: Washington
country: United States
facility: MedStar Health Research Institute
state: District of Columbia
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Pensacola
country: United States
facility: Sacred Heart
state: Florida
city: Indianapolis
country: United States
facility: St. Vincent Heart Center of Indiana
state: Indiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Brighton
country: United States
facility: St. Elizabeth's Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: Bay State Hospital
state: Massachusetts
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Hospital
state: Minnesota
city: Billings
country: United States
facility: St. Vincent Heart and Vascular Center of Montana
state: Montana
city: Lincoln
country: United States
facility: Nebraska Heart Institute
state: Nebraska
city: Camden
country: United States
facility: Cooper Hospital
state: New Jersey
city: Charlotte
country: United States
facility: Carolinas Health Care
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Heart and Vascular Institue
state: Pennsylvania
city: Houston
country: United States
facility: St. Luke's Medical Center
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Temple
country: United States
facility: Scott & White Healthcare System
state: Texas
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Froedtert Memorial Lutheran Hospital (Medical College of Wisconsin)
state: Wisconsin
city: Heidelberg
country: Germany
facility: University of Heidelberg
state: Baden-Württemberg
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
Study officials:
affiliation: Cooper Hospital, Camden, NJ
name: Jeffrey Carpenter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: Carpenter JP, Lane JS 3rd, Trani J, Hussain S, Healey C, Hashemi H, Cuff R; Nellix Investigators. Proper technical procedures improved outcomes in a retrospective analysis of EVAS FORWARD IDE trial 3-year results. J Vasc Surg. 2020 Sep;72(3):918-930.e2. doi: 10.1016/j.jvs.2019.11.039. Epub 2020 Feb 5.
citation: Carpenter JP, Lane JS 3rd, Trani J, Hussain S, Healey C, Buckley CJ, Hashemi H, Cuff R; Nellix Investigators. Refinement of anatomic indications for the Nellix System for endovascular aneurysm sealing based on 2-year outcomes from the EVAS FORWARD IDE trial. J Vasc Surg. 2018 Sep;68(3):720-730.e1. doi: 10.1016/j.jvs.2018.01.031. Epub 2018 Mar 31.
citation: Carpenter JP, Cuff R, Buckley C, Healey C, Hussain S, Reijnen MM, Trani J, Bockler D; Nellix Investigators. Results of the Nellix system investigational device exemption pivotal trial for endovascular aneurysm sealing. J Vasc Surg. 2016 Jan;63(1):23-31.e1. doi: 10.1016/j.jvs.2015.07.096. Epub 2015 Oct 21.