CP-0010 Evas-Global Version 2.0
Research type
Research Study
Full title
Multicenter, Observational, Registry to Assess Outcomes of Patients Treated with the CE Marked Nellix® System for Endovascular Abdominal Aortic Aneurysm Repair”\nNellix Registry Study: EVAS-Global
IRAS ID
218329
Contact name
Rita Herrenknecht
Contact email
Sponsor organisation
Endologix, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 9 months, 31 days
Research summary
This Evas Global 2 Registry is designed to evaluate the clinical outcomes of the Nellix® System by collecting data on treated patient conditions and on the device. Patients diagnosed with an abdominal aortic aneurysm (a bulge in the aorta, known as AAA) are considered eligible to be enrolled in the Registry.\nAn aneurysm can be treated with surgical repair, but also with a less invasive procedure by placing a tube (called stent graft) inside the aneurysm via an artery in the groin and this procedure is called endovascular aneurysm repair. \nEndovascular anurysm repair may provide clinical benefits for patient because is less invasive, has lower complication rates, and has the potential for faster recovery time than major surgical device. The study results will be contributing to the advancement of this technique, which may prove beneficial to treated patients and future ones.\nUp to 40 sites in Europe and Asia Pacific area and approximately 300 subjects will participate to this Study. \nEnrolled patients will be followed procedurally to discharge, as per institutional standard of care thereafter through to 5 years. Patients’ conditions will be closely monitored by regular standard of care visits, which typically take place at one month, six month, one year and yearly thereafter. During these visits patients will have a physical and medical examination, blood test and imaging, computer tomography (CTA) or Duplex Ultrasound examination (DUS), depending on the standard of care practice of the Investigator.
REC name
South West - Frenchay Research Ethics Committee
REC reference
17/SW/0081
Date of REC Opinion
31 Aug 2017
REC opinion
Further Information Favourable Opinion