Clinical trial NCT02996396: Nellix Registry Study: EVAS-Global
Official title: Multicenter, Observational, Registry to Assess Outcomes of Patients Treated With the CE Marked Nellix® System for Endovascular Abdominal Aortic Aneurysm Repair"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abdominal Aortic Aneurysm
Keywords: AAA, Aortoiliac Aneurysm
Lead sponsor: Endologix
Sponsor class: INDUSTRY
First posted: 2016-12-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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)


Eligibility 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)

Primary outcomes:
measure: Number of subjects with Immediate Procedural Technical Success
timeFrame: 30 Days
measure: Safety assessment by Number of subjects with absence of Major Adverse Events (MAEs)
timeFrame: 30 Days
measure: Number of subjects with Aneurysm rupture
timeFrame: 5 years
measure: Number of subjects with Conversion to open surgical repair
timeFrame: 5 years
measure: Number of subjects with Endoleak of any type
timeFrame: 5 years
measure: Number of subjects with Clinically significant migration
timeFrame: 5 years
measure: Number of subjects with Aneurysm enlargement
timeFrame: 5 years
measure: Number of incidence with Secondary endovascular procedures
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
measure: Number of subjects with incidence of device patency and integrity
timeFrame: 5 years
measure: Number of incidence with Distal Complications
timeFrame: 5 years
Locations:
city: Augsburg
country: Germany
facility: Klinikum Augsburg Klinik für Gefäßchirurgie
city: Bonn
country: Germany
facility: St. Marien Hospital Bonn
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
city: Koeln
country: Germany
facility: University Hospital Koeln
city: Munich
country: Germany
facility: TUM Munich
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Tilburg
country: Netherlands
facility: St Elisabeth Ziekenhuis, Dept of Vascular Surgery
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico de La Fe
Study officials:
affiliation: Auckland City Hospital
name: Andrew Holden, MBChB
role: PRINCIPAL_INVESTIGATOR
affiliation: Rijnstate, Arnhem, the Netherlands
name: Michel Reijnen, MD
role: PRINCIPAL_INVESTIGATOR
References: