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

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ClinicalTrials.gov Identifier: NCT01726257
Recruitment Status : Recruiting
First Posted : November 14, 2012
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):

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
Abdominal Aortic Aneurysm (AAA) Device: Nellix System

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  (Clinical Trial)
Estimated Enrollment : 429 participants
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
Study Start Date : December 2013
Primary Completion Date : June 2016
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Nellix System
The Nellix EndoVascular Aneurysm Sealing System ( Nellix System ) will be implanted into patients with an infrarenal abdominal aortic aneurysm (AAA).
Device: Nellix System
Other Name: Nellix Endovascular Aneurysm Sealing System


Outcome Measures

Primary Outcome Measures :
  1. Safety [ Time Frame: 30 days ]
    Major Adverse Events = all-cause death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, and blood loss >1,000cc

  2. Effectiveness [ Time Frame: 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 :
  1. Safety [ Time Frame: >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

  2. Clinical Utility Outcomes [ Time Frame: At the time of procedure ]
    anesthesia time; fluoroscopy time; contrast volume; estimated blood loss; % requiring transfusion; procedure time

  3. Time in ICU [ Time Frame: Up to 7 days ]
    Number of hours spent in the intensive care unit (ICU)

  4. Adverse Events [ Time Frame: > 30 days to 5 years ]
    All serious and non-serious events within 30 days, at 6 months, and at 1 to 5 years

  5. Aneurysm Rupture [ Time Frame: > 30 days to 5 years ]
  6. Conversion to Open-Surgical Repair [ Time Frame: >30 days to 5 years ]
  7. Device Performance [ Time Frame: > 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

  8. Mortality [ Time Frame: > 30 days to 5 years ]
  9. Renal Dysfunction [ Time Frame: Post-procedure to 5 years ]
    assessment of estimated glomerular filtration rate (eGFR)

  10. Secondary Surgical Intervention [ Time Frame: 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.

  11. Time to Hospital Discharge [ Time Frame: Up to 7 days ]
    Number of days spent in hospital


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01726257


Contacts
Contact: Peter Miller 949-595-7200 pmiller@endologix.com

  Show 30 Study Locations
Sponsors and Collaborators
Endologix
Investigators
Principal Investigator: Jeffrey Carpenter, MD Cooper Hospital, Camden, NJ
More Information