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Nellix Registry Study: EVAS-Global (EVAS FORWARD 2)

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ClinicalTrials.gov Identifier: NCT02996396
Recruitment Status : Recruiting
First Posted : December 19, 2016
Last Update Posted : December 19, 2016
Sponsor:
Information provided by (Responsible Party):
Endologix

Brief Summary:
Multicenter, single arm, open label, registry study with consecutive, eligible patient enrollment at each site. All subjects undergoing the Endovascular Aneurysm Sealing System (EVAS) with the Nellix®-System. Subjects will be followed procedurally to discharge, and as per institutional standard of care thereafter through to 5 years (total follow-up commitment)

Condition or disease Intervention/treatment
Abdominal Aortic Aneurysm Device: Nellix Endovascular Aneurysm Sealing System (Nellix®-System)

Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 60 Months
Official Title: Multicenter, Observational, Registry to Assess Outcomes of Patients Treated With the CE Marked Nellix® System for Endovascular Abdominal Aortic Aneurysm Repair"
Study Start Date : November 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
1
Patients diagnosed with AAA who are considered candidates for Endovascular Repair and meet the study eligibility criteria and sign the Informed consent may be subsequently enrolled in the study.
Device: Nellix Endovascular Aneurysm Sealing System (Nellix®-System)
The Nellix system is comprised of two independent flow channels, one to each iliac artery. Each flow channel consists of a balloon-expanded ePTFE covered stent surrounded by a Polymer-filled EndoBag which fills the blood lumen within the aorta, and seals the aneurysm from side-branch flow.
Other Name: Nellix EVAS FORWARD 2




Primary Outcome Measures :
  1. Number of subjects with Immediate Procedural Technical Success [ Time Frame: 30 Days ]
    Technical success is defined as successful delivery and deployment of the Nellix System in the planned location.

  2. Safety assessment by Number of subjects with absence of Major Adverse Events (MAEs) [ Time Frame: 30 Days ]
    Safety endpoint is measured with the number of subjects who are reported freedome of major adverse events (MAEs) including (1) all-cause death, (2) bowel ischemia, (3) myocardial infarction, (4) paraplegia, (5) renal failure, (6) respiratory failure, (7) stroke, and (8) Blood Loss > 1000mL at 30 Days post index procedure.


Other Outcome Measures:
  1. Number of subjects with Aneurysm rupture [ Time Frame: 5 years ]
    The number of patients experiencing a rupture of the aneurysm will be summarized at 30 days and within each follow-up window (i.e., six months, and annually at years 1 through 5).

  2. Number of subjects with Conversion to open surgical repair [ Time Frame: 5 years ]
    The number of patients undergoing surgical conversion to open repair will be provided at 30 days and within each follow-up window (i.e., six months, and annually at years 1 through 5).

  3. Number of subjects with Endoleak of any type [ Time Frame: 5 years ]
    The number of patients with any endoleak, and patients with each endoleak type at 30 days and within each follow-up window (i.e., six months, and annually at years 1 through 5) will be summarized.

  4. Number of subjects with Clinically significant migration [ Time Frame: 5 years ]
    The number of patients with clinically significant migration will be summarized descriptively.

  5. Number of subjects with Aneurysm enlargement [ Time Frame: 5 years ]
    The number of patients with Aneurysm enlargement will be summarized descriptively. Sac enlargement is defined in the protocol as increase in late follow-up compared to the initial post-op measurement.

  6. Number of incidence with Secondary endovascular procedures [ Time Frame: 5 years ]
    The overall secondary procedure incidence and the individual component incidence will be provided.

  7. Number of incidence with Distal Complications [ Time Frame: 5 years ]
    The number of incidence of distal thrombosis, embolization and iliac stenosis will be summarized.

  8. Number of subjects with incidence of device patency and integrity [ Time Frame: 5 years ]
    Device patency and integrity will be measured by the number and proportion of patients at 30 days, 6 months, and 1 year to 5 years including Stent Kinking, Lumen Occlusion, and Stent Fracture.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with AAA who are considered candidates for Endovascular Repair and meet the study eligibility criteria and sign the Informed consent may be subsequently enrolled in the study.
Criteria

Inclusion Criteria:

  1. Male or female at least 18 years old
  2. Subject has signed informed consent for data release
  3. Subjects with with AAA and eligible for endovascular repair

Exclusion Criteria:

  1. Currently participating in another study where primary endpoint has not been reached yet
  2. Known allergy to any of the device components
  3. Pregnant (females of childbearing potential only)

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): NCT02996396


Contacts
Contact: Frederick M Arbour 949-598-4667 marbour@endologix.com
Contact: Sanae Horowitz 949-452-2542 shorowitz@endologix.com

Locations
New Zealand
Auckland City Hospital Recruiting
Auckland, New Zealand
Contact: Andrew Holden, MBChB       AndrewH@adhb.govt.nz   
Contact: Helen Knight       HKnight@adhb.govt.nz   
Sponsors and Collaborators
Endologix
Investigators
Principal Investigator: Andrew Holden, MBChB Auckland City Hospital
Principal Investigator: Michel Reijnen, MD Rijnstate, Arnhem, the Netherlands

Responsible Party: Endologix
ClinicalTrials.gov Identifier: NCT02996396     History of Changes
Other Study ID Numbers: CP0010 Ver. 2
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: December 19, 2016
Last Verified: December 2016

Keywords provided by Endologix:
AAA, Aortoiliac Aneurysm

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