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The Nellix® EndoVascular Aneurysm Sealing System for the Treatment of Infrarenal Abdominal Aortic Aneurysms

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ClinicalTrials.gov Identifier: NCT02048514
Recruitment Status : Unknown
Verified January 2014 by Endologix.
Recruitment status was:  Active, not recruiting
First Posted : January 29, 2014
Last Update Posted : January 29, 2014
Sponsor:
Information provided by (Responsible Party):
Endologix

Brief Summary:
The purpose of this clinical study is to evaluate the safety and device performance of the Nellix® EndoVascular Aneurysm Sealing System (Nellix System) for the treatment of infrarenal abdominal aortic aneurysms.

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysms Device: The Nellix® EndoVascular Aneurysm Sealing System Not Applicable

Detailed Description:
This is a multicenter, multi-country prospective, single-arm, non-randomized clinical trial. The comparative control arm is a combination of patient data drawn from the abdominal aortic aneurysms (AAA) open surgical control arms of four commercially approved AAA devices as part of the Society of Vascular Surgeons. Patients enrolled in this study will be pre-screened and have a diagnosis of an infrarenal AAA with or without the need for treatment of iliac artery aneurysm, are candidates for endovascular repair, and meet the eligibility criteria. Patients enrolled in the study will participate in follow-up visits 31 days, 6 months and at 1 year following the index procedure. At the follow-up visits there will be a clinical assessment, blood collection, and abdominal CT imaging of the patient.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Nellix® EndoVascular Aneurysm Sealing System for the Treatment of Infrarenal Abdominal Aortic Aneurysms
Study Start Date : December 2008
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nellix Aneurysm Sealing
The Nellix® EndoVascular Aneurysm Sealing System
Device: The Nellix® EndoVascular Aneurysm Sealing System



Primary Outcome Measures :
  1. Safety [ Time Frame: 30 day ]
    The primary safety endpoint is defined as the incidence of Major Adverse Events (MAE) through 30 days after the index procedure.

  2. Device Performance [ Time Frame: 30 days ]
    The primary performance endpoint is technical success defined as successful delivery and deployment of the device and freedom from open surgical conversion at 30 days.


Secondary Outcome Measures :
  1. All Cause Mortality [ Time Frame: 12 months ]
    Any death occurring during the study period, regardless of cause



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age
  • Informed consent form understood and signed and patient agrees to all follow-up visits
  • Is able and willing to comply with clinical follow-up requirements for one year
  • Is able and willing to undergo Contrast-Enhanced Spiral CT scans
  • Is a candidate for endovascular repair of an infrarenal aortic aneurysm with or without an iliac aneurysm with at least one of the following;

    1. aneurysm ≥ 4.5 cm in diameter, or
    2. aneurysm is twice the diameter of the normal infrarenal aorta, or
    3. aneurysm is growing at a rate of ≥ 10 % per year
  • Non-aneurysmal aortic neck length ≥ 5mm below the most inferior renal artery
  • Proximal aortic neck diameter between 16 and 36mm
  • Aortic neck angulation to the sac ≤ 60
  • Common iliac artery diameter 8 to 35mm bilaterally
  • Aneurysm blood lumen diameter ≤ 60mm
  • Iliac and femoral arteries suitable for endovascular access with the Nellix System

Exclusion Criteria:

  • Life expectancy ≤ 1 year
  • Dissecting, ruptured, or leaking aneurysm (blood outside the aorta), has sustained recent trauma, is symptomatic, or is non-degenerative
  • Aneurysm is thoraco-abdominal, suprarenal and/or mycotic
  • Thoracic aneurysm ≥ 4.5cm in diameter
  • AAA requires treatment that would result in bilateral occlusion of the internal iliac arteries
  • Presence of mural thrombus > 50% circumferentially in aortic neck
  • Iliac aneurysm blood lumen diameter > 35mm
  • Active infection, vasculitis, or systemic connective tissue disease (e.g., Rheumatoid arthritis, scleroderma, Marfan's syndrome, Ehlers-Danlos disease) at time of procedure
  • History of prior treatment of abdominal aortic or iliac artery aneurysm disease
  • Femoral or iliac artery occlusive disease such that device delivery is not possible
  • Vascular access for delivery of device requires placement of vascular conduit or is through an established vascular graft
  • Receiving dialysis
  • History of hypercoagulability
  • Allergy to IV contrast
  • Serum creatinine level >2.0 mg/dL (or equivalent)
  • Patient is pregnant or nursing
  • Patient is currently enrolled in an investigational drug or device trial

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): NCT02048514


Locations
Colombia
Centro Medico de Cali
Cali, Colombia, 24-157
Latvia
Paul Stradins University Hospital
Riga, Latvia, LV-1007
New Zealand
Auckland City Hospital
Auckland, New Zealand, 1142
Venezuela
Instituto de Clinicas Y Urologica Tomanaco
Caracas, Venezuela
Sponsors and Collaborators
Endologix

Responsible Party: Endologix
ClinicalTrials.gov Identifier: NCT02048514     History of Changes
Other Study ID Numbers: N09-01
First Posted: January 29, 2014    Key Record Dates
Last Update Posted: January 29, 2014
Last Verified: January 2014

Keywords provided by Endologix:
Aortic Aneurysm, Abdominal
Endovascular Procedures

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