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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nellix System | Experimental | Nellix Endovascular Aneurysm Sealing System is the only arm for this study. This is a single arm study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nellix System | Device | Subjects in this study will receive a Nellix Endovascular Sealing System as part of their intervention. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Treatment Success at 1 Year | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Carpenter, MD | Cooper Hospital, Camden, NJ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson Medical Center | Tucson | Arizona | 85712 | United States | ||
| VA San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22885361 | Background | 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. | |
| 21497521 | Background | 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. |
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Up to 180 subjects will be enrolled at a maximum of 30 sites in the EU, and US in the Primary Investigation. This includes up to 30 Roll-in subjects and up to 150 patients in the Intent to Treat Pivotal Cohort. At enrollment closure for the Primary Investigation, an Extended Investigation will commence at these sites to enroll up to 250 additional subjects under continued access provisions. The protocol allowed up to 430 total subjects, however, the actual enrollment total was 333.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pivotal Cohort (ITT) | The Intention to Treat Pivotal Cohort includes up to 150 subjects will be enrolled at a maximum of 30 sites in the US and the EU.This includes the statistically justified sample size of 132 plus an allowance for deviations from assumptions. |
| FG001 | Roll-In Cohort |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 6, 2018 |
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| San Diego |
| California |
| 92161 |
| United States |
| Yale University | New Haven | Connecticut | 06437 | United States |
| Christiana Care Hospital | Newark | Delaware | 19713 | United States |
| MedStar Health Research Institute | Washington D.C. | District of Columbia | 20010 | United States |
| Baptist Hospital of Miami | Miami | Florida | 33176 | United States |
| Sacred Heart | Pensacola | Florida | 32504 | United States |
| St. Vincent Heart Center of Indiana | Indianapolis | Indiana | 46077 | United States |
| Maine Medical Center | Portland | Maine | 04102 | United States |
| St. Elizabeth's Medical Center | Brighton | Massachusetts | 02135 | United States |
| Bay State Hospital | Springfield | Massachusetts | 01199 | United States |
| Spectrum Health | Grand Rapids | Michigan | 49546 | United States |
| Minneapolis Hospital | Minneapolis | Minnesota | 55407 | United States |
| St. Vincent Heart and Vascular Center of Montana | Billings | Montana | 59101 | United States |
| Nebraska Heart Institute | Lincoln | Nebraska | 68526 | United States |
| Cooper Hospital | Camden | New Jersey | 08102 | United States |
| Carolinas Health Care | Charlotte | North Carolina | 28203 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Ohio Health Research Institute | Columbus | Ohio | 43214 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| UPMC Heart and Vascular Institue | Pittsburgh | Pennsylvania | 15232 | United States |
| St. Luke's Medical Center | Houston | Texas | 77030 | United States |
| The Heart Hospital Baylor Plano | Plano | Texas | 75093 | United States |
| Scott & White Healthcare System | Temple | Texas | 76508 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| Providence Sacred Heart Medical Center | Spokane | Washington | 99204 | United States |
| Froedtert Memorial Lutheran Hospital (Medical College of Wisconsin) | Milwaukee | Wisconsin | 53226 | United States |
| University of Heidelberg | Heidelberg | Baden-Wurttemberg | D-69120 | Germany |
| Rijnstate Hospital | Arnhem | 90 | Netherlands |
| Addenbrooke's Hospital | Cambridge | CB2 0QQ | United Kingdom |
| 32035772 | Derived | 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. |
| 29609994 | Derived | 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. |
| 26482997 | Derived | 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. |
One (1) roll-in subject may be enrolled per site, therefore a maximum of 30 enrolled in the study, to allow for Investigator(s) to receive additional training on the Nellix System. Any roll-in subjects will be screened, consented, treated and followed identically to the main study cohort.However, the roll-in cohort of this study will be evaluated separately. |
| FG002 | Continued Access Cohort | Up to 250 patients will be enrolled into the Extended Investigation based on an enrollment rate of 0.5 patients per site per month and an estimated 20 months from the close of enrollment in the Primary Investigation. Enrollment in Extended Investigation (continued access) phase will be limited to the 27 US sites only as the Nellix System is commercially available to the three participating European sites. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pivotal Cohort | Subject Demographics for the Pivotal cohort |
| BG001 | Roll-In Cohort | Subject Demographics for the Roll-in cohort |
| BG002 | Continued Access Cohort | Subject Demographics for the Continued Access cohort |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 30 days |
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| Primary | Treatment Success at 1 Year | 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. | Posted | Count of Participants | Participants | 1 year |
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All serious and non-serious events within 30 days, at 6 months, and annually to 5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pivotal Cohort (ITT) | The Intention to Treat Pivotal Cohort includes up to 150 subjects will be enrolled at a maximum of 30 sites in the US and the EU.This includes the statistically justified sample size of 132 plus an allowance for deviations from assumptions. | 1 | 150 | 26 | 150 | 38 | 150 |
| EG001 | Roll-In Cohort | One (1) roll-in subject may be enrolled per site, therefore a maximum of 30 enrolled in the study, to allow for Investigator(s) to receive additional training on the Nellix System. Any roll-in subjects will be screened, consented, treated and followed identically to the main study cohort.However, the roll-in cohort of this study will be evaluated separately. | 0 | 29 | 5 | 29 | 7 | 29 |
| EG002 | Continued Access Cohort | Up to 250 patients will be enrolled into the Extended Investigation based on an enrollment rate of 0.5 patients per site per month and an estimated 20 months from the close of enrollment in the Primary Investigation. Enrollment in Extended Investigation (continued access) phase will be limited to the 27 US sites only as the Nellix System is commercially available to the three participating European sites. | 1 | 154 | 37 | 154 | 40 | 154 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding/Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Bowel | Gastrointestinal disorders | Systematic Assessment |
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| Cardiac | Cardiac disorders | Systematic Assessment |
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| Malignancies | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Miscellaneous | General disorders | Systematic Assessment |
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| Nellix Device | Product Issues | Systematic Assessment |
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| Neurological | Psychiatric disorders | Systematic Assessment |
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| Pulmonary | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Renal | Renal and urinary disorders | Systematic Assessment |
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| Surgical Site Wound | Injury, poisoning and procedural complications | Systematic Assessment |
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| Urogenital | Renal and urinary disorders | Systematic Assessment |
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| Vascular | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding/Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Bowel | Gastrointestinal disorders | Systematic Assessment |
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| Cardiac | Cardiac disorders | Systematic Assessment |
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| Malignancies | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Miscellaneous | General disorders | Systematic Assessment |
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| Nellix Device | Product Issues | Systematic Assessment |
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| Neurological | Nervous system disorders | Systematic Assessment |
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| Pulmonary | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Renal | Renal and urinary disorders | Systematic Assessment |
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| Surgical Site Wound | Surgical and medical procedures | Systematic Assessment |
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| Urogenital | Renal and urinary disorders | Systematic Assessment |
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| Vascular | Vascular disorders | Systematic Assessment |
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| Wound | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tammy Stiver | Endologix | 5136731452 | tstiver@endologix.com |
| Mar 1, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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| Male |
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| Non-Caucasian |
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