Nellix® Registry Study: EVAS-Global

NCT02018744 | Unknown

• 1 other identifier: CP0010-Ver. 1
• Study Type: observational
• Target: 300
• Locations: 8 countries
• Sites: 19

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.

Conditions

Safety and Performance of the Nellix Endovascular Sealing System

Outcome Measures

Primary Outcomes (3)

• Immediate procedural technical success

  Number of subjects where immediate procedural technical success during procedure was noted

  Procedure

• Peri-operative Safety Parameters

  Number of subjects with procedural Blood loss \>1000mL, Mortality (all-cause), Bowel Ischemia, Paraplegia, Renal Failure, Myocardial Infarction, Respiratory Failure, Stroke

  Up to 30 days

• Clinical outcome

  Number of subjects with Aneurysm rupture, Conversion to open surgical repair, Endoleak of any type, Clinically significant migration, Aneurysm enlargement through to five years, Secondary endovascular procedures of any type through to five years, Secondary endovascular procedures for (resolution of Endoleak of any type; Device occlusion (due to thrombus or other causes); Device migration AAA sac expansion (\>5mm diameter increase); Device defect)

  Up to 5 years

Other Outcomes (3)

• Device Patency and Integrity

  Up to 5 years

• In-hospital evaluations

  Discharge

• Distal Complications

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Endologix: lead

Study Sites (19)

Klinikum Augsburg Klinik für Gefäßchirurgie

Augsburg, 86156, Germany

Location

Universitätsklinikum Düsseldorf Klinik für Gefäß- und Endovaskularchirurgie

Düsseldorf, 40225, Germany

Location

Alfried Krupp Krankenhaus Ruttenscheid, Vascular Centre

Essen, 45131, Germany

Location

Universitätsklinikum Heidelberg Klinik für Gefäßchirurgie Im Neuenheimer Feld

Heidelberg, 69120, Germany

Location

Klinikum Sud Nuernberg, Dept of Vascular Surgery

Nuremberg, 90471, Germany

Location

Klinikum Stuttgart Katharinenen Hospital

Stuttgart, 70174, Germany

Location

Pauls Stadins Clinical University Hospital Riga

Riga, LV-1002, Latvia

Location

Hopital Kirchberg, Dept of Cardio-Vascular

Luxembourg-Kirchberg, L-2540, Luxembourg

Location

Academisch Medisch Centrum Amsterdam, Department of Surgery

Amsterdam, 1105AZ, Netherlands

Location

Rijnstate Ziekenhuis, Vasculaire Centrum

Arnhem, 6800 TA, Netherlands

Location

St Antonius Ziekenhuis, Dept of Vascular Surgery

Nieuwegein, 3435 CM, Netherlands

Location

Erasmus Medical Centre, Dept of Vascular Surgery

Rotterdam, 3015 CE, Netherlands

Location

St Elisabeth Ziekenhuis, Dept of Vascular Surgery

Tilburg, 5022 GC, Netherlands

Location

Auckland City Hospital Interventional Radiology

Auckland, 1023, New Zealand

Location

Hospital Hamar

Hamar, 2326, Norway

Location

Orebro University Hospital, Department of General Surgery

Örebro, Sweden

Location

Karolinska University Hospital

Stockholm, SE-171, Sweden

Location

Addenbrooke's Hospital, Dept of Vascular Surgery

Cambridge, CB20QQ, United Kingdom

Location

St. George's Vascular Institute

London, SW170QT, United Kingdom

Location

Study Officials

• Prof Andrew Holden

  Auckland City Hospital

  PRINCIPAL INVESTIGATOR

• Dr. Michel Reijnen, MD

  Rijnstate Hospital, Arnhem NL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: December 23, 2013
• Study Start: October 1, 2013
• Primary Completion: September 1, 2019
• Study Completion: June 30, 2022
• Last Updated: March 3, 2022

Record last verified: 2022-03

Locations

DE (6); GB (2); SE (2); LA (1); NZ (1); NL (5); LU (1); NO (1)