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

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Abdominal aortic aneurysm
Related Access Program
Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

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

Official Title

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

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.

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

Primary Outcome

Safety- Number of Major Adverse Events

Secondary Outcome

 All Cause Mortality

Condition

Abdominal Aortic Aneurysms

Intervention

The Nellix® EndoVascular Aneurysm Sealing System

Study Arms / Comparison Groups

 Nellix Aneurysm Sealing
Description:  The Nellix® EndoVascular Aneurysm Sealing System

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

69

Start Date

December 2008

Completion Date

December 2017

Primary Completion Date

December 2017

Eligibility 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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

Colombia

Location Countries

Colombia

Administrative Informations

NCT ID

NCT02048514

Organization ID

N09-01

Responsible Party

Sponsor

Study Sponsor

Endologix

Study Sponsor

, ,

Verification Date

March 2021