Trial record 9 of 211 for:    Open Studies | UCSD OR UC San Diego OR VA San Diego

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

This study is currently recruiting participants.
Verified April 2014 by Endologix
Sponsor:
Information provided by (Responsible Party):
Endologix
ClinicalTrials.gov Identifier:
NCT01726257
First received: October 19, 2012
Last updated: April 2, 2014
Last verified: April 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: July 2019
Estimated Primary Completion Date: July 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726257

Contacts
Contact: Darren LaCour 949-598-4671 dlacour@endologix.com
Contact: Peter Miller 949-598-4693 pmiller@endologix.com

  Show 29 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: April 2, 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
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on April 20, 2014