Clinical trial NCT02018744: Nellix® Registry Study: EVAS-Global
Official title: Multicenter, Observational, Post-Market, Real World Registry to Assess Outcomes of Patients Treated With the Nellix® System for Endovascular Abdominal Aortic Aneurysm Repair
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Safety and Performance of the Nellix Endovascular Sealing System
Lead sponsor: Endologix
Sponsor class: INDUSTRY
First posted: 2013-12-23
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: PROBABILITY_SAMPLE
Study population: Up to 300 patients diagnosed with AAA who are considered candidates for Endovascular Repair, who meet the study eligibility criteria and sign the Informed consent may be subsequently enrolled in the study

Brief summary: This registry has been designed as a multicenter, single arm, open label, post-market 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 up to discharge discharge, and as per institutional standard of care thereafter through to 5 years (total follow-up commitment). This registry of the Nellix System, which has received the market authorization of the European Union (Conformité Européenne, CE-certification) in a "real world" patient population treated in a multicenter setting will provide an assessment of the generalizability of the approach and System.

Up to 300 patients diagnosed with abdominal aortic aneurysm (AAA) who are considered candidates for Endovascular Repair, in up to 30 international centers will be enrolled in the study.

Detailed description: 1. Baseline: medical history, physical exams, CT image, bloodwork,
2. Procedure: implantation information
3. Discharge: Physical exam, bloodwork and adverse events, if any
4. Follow-up according to institutional standard through to 5 years including Physical exam, CT image or standard of care imaging eg Doppler Ultrasound, bloodwork and adverse events, if any

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 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: Immediate procedural technical success
timeFrame: Procedure
measure: Peri-operative Safety Parameters
timeFrame: Up to 30 days
measure: Clinical outcome
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
measure: Device Patency and Integrity
timeFrame: Up to 5 years
measure: In-hospital evaluations
timeFrame: Discharge
measure: Distal Complications
timeFrame: 5 years
Locations:
city: Augsburg
country: Germany
facility: Klinikum Augsburg Klinik für Gefäßchirurgie
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf Klinik für Gefäß- und Endovaskularchirurgie
city: Essen
country: Germany
facility: Alfried Krupp Krankenhaus Ruttenscheid, Vascular Centre
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg Klinik für Gefäßchirurgie Im Neuenheimer Feld
city: Nuernberg
country: Germany
facility: Klinikum Sud Nuernberg, Dept of Vascular Surgery
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart Katharinenen Hospital
city: Riga
country: Latvia
facility: Pauls Stadins Clinical University Hospital Riga
city: Luxembourg-Kirchberg
country: Luxembourg
facility: Hopital Kirchberg, Dept of Cardio-Vascular
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum Amsterdam, Department of Surgery
city: Arnhem
country: Netherlands
facility: Rijnstate Ziekenhuis, Vasculaire Centrum
city: Nieuwegein
country: Netherlands
facility: St Antonius Ziekenhuis, Dept of Vascular Surgery
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Centre, Dept of Vascular Surgery
city: Tilburg
country: Netherlands
facility: St Elisabeth Ziekenhuis, Dept of Vascular Surgery
city: Auckland
country: New Zealand
facility: Auckland City Hospital Interventional Radiology
city: Hamar
country: Norway
facility: Hospital Hamar
city: Orebro
country: Sweden
facility: Orebro University Hospital, Department of General Surgery
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital, Dept of Vascular Surgery
city: London
country: United Kingdom
facility: St. George's Vascular Institute
Study officials:
affiliation: Auckland City Hospital
name: Prof Andrew Holden
role: PRINCIPAL_INVESTIGATOR
affiliation: Rijnstate Hospital, Arnhem NL
name: Dr. Michel Reijnen, MD
role: PRINCIPAL_INVESTIGATOR
References: