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

Study Status: Enrolling by invitation
Recruit Status: Unknown status
Study Type: Interventional

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 Summary: 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.
Sponsor: Endologix

Current Primary Outcome:

  • 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.
  • 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: All Cause Mortality [ Time Frame: 12 months ]

Any death occurring during the study period, regardless of cause


Original Secondary Outcome: Same as current

Information By: Endologix

Dates:
Date Received: January 27, 2014
Date Started: December 2008
Date Completion: January 2014
Last Updated: January 27, 2014
Last Verified: January 2014