Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Endologix
Sponsor:
Information provided by (Responsible Party):
Endologix
ClinicalTrials.gov Identifier:
NCT01726257
First received: October 19, 2012
Last updated: October 21, 2014
Last verified: October 2014
  Purpose

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 Intervention
Abdominal Aortic Aneurysm (AAA)
Device: Nellix System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Endologix:

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

  • Effectiveness [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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:
  • Safety [ Time Frame: >30 days to 5 years ] [ Designated as safety issue: Yes ]
    Major Adverse Events = all-cause death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, and blood loss >1,000cc

  • Clinical Utility Outcomes [ Time Frame: At the time of procedure ] [ Designated as safety issue: Yes ]
    anesthesia time; fluoroscopy time; contrast volume; estimated blood loss; % requiring transfusion; procedure time

  • Time in ICU [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]
    Number of hours spent in the intensive care unit (ICU)

  • Adverse Events [ Time Frame: > 30 days to 5 years ] [ Designated as safety issue: Yes ]
    All serious and non-serious events within 30 days, at 6 months, and at 1 to 5 years

  • Aneurysm Rupture [ Time Frame: > 30 days to 5 years ] [ Designated as safety issue: Yes ]
  • Conversion to Open-Surgical Repair [ Time Frame: >30 days to 5 years ] [ Designated as safety issue: Yes ]
  • Device Performance [ Time Frame: > 30 days to 5 years ] [ Designated as safety issue: Yes ]
    aneurysm sac diameter change from the first post-operative CT scan, device migration, device patency, device integrity, incidence of endoleak

  • Mortality [ Time Frame: > 30 days to 5 years ] [ Designated as safety issue: Yes ]
  • Renal Dysfunction [ Time Frame: Post-procedure to 5 years ] [ Designated as safety issue: Yes ]
    assessment of estimated glomerular filtration rate (eGFR)

  • Secondary Surgical Intervention [ Time Frame: Post-procedure to 5 years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]
    Number of days spent in hospital


Estimated Enrollment: 180
Study Start Date: December 2013
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 ≥5.5cm, 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 16 to 32mm; angle ≤60° to the aneurysm sac;
  • Common iliac artery lumen diameter between 8 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726257

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

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

Publications:
Responsible Party: Endologix
ClinicalTrials.gov Identifier: NCT01726257     History of Changes
Other Study ID Numbers: CP-0008
Study First Received: October 19, 2012
Last Updated: October 21, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Endologix:
Infrarenal
Abdominal
Aortic
Aneurysm
AAA
Endologix
EVAS
EndoVascular
Sealing
System

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Aortic Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014