- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02018744
Nellix® Registry Study: EVAS-Global (EVAS-FORWARD 1)
Multicenter, Observational, Post-Market, Real World Registry to Assess Outcomes of Patients Treated With the Nellix® System for Endovascular Abdominal Aortic Aneurysm Repair
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.
Study Overview
Status
Detailed Description
- Baseline: medical history, physical exams, CT image, bloodwork,
- Procedure: implantation information
- Discharge: Physical exam, bloodwork and adverse events, if any
- 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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Augsburg, Germany, 86156
- Klinikum Augsburg Klinik für Gefäßchirurgie
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Düsseldorf, Germany, 40225
- Universitätsklinikum Düsseldorf Klinik für Gefäß- und Endovaskularchirurgie
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Essen, Germany, 45131
- Alfried Krupp Krankenhaus Ruttenscheid, Vascular Centre
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Heidelberg, Germany, 69120
- Universitätsklinikum Heidelberg Klinik für Gefäßchirurgie Im Neuenheimer Feld
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Nuernberg, Germany, 90471
- Klinikum Sud Nuernberg, Dept of Vascular Surgery
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Stuttgart, Germany, 70174
- Klinikum Stuttgart Katharinenen Hospital
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Riga, Latvia, LV-1002
- Pauls Stadins Clinical University Hospital Riga
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Luxembourg-Kirchberg, Luxembourg, L-2540
- Hopital Kirchberg, Dept of Cardio-Vascular
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Amsterdam, Netherlands, 1105AZ
- Academisch Medisch Centrum Amsterdam, Department of Surgery
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Arnhem, Netherlands, 6800 TA
- Rijnstate Ziekenhuis, Vasculaire Centrum
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Nieuwegein, Netherlands, 3435 CM
- St Antonius Ziekenhuis, Dept of Vascular Surgery
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Rotterdam, Netherlands, 3015 CE
- Erasmus Medical Centre, Dept of Vascular Surgery
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Tilburg, Netherlands, 5022 GC
- St Elisabeth Ziekenhuis, Dept of Vascular Surgery
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Auckland, New Zealand, 1023
- Auckland City Hospital Interventional Radiology
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Hamar, Norway, 2326
- Hospital Hamar
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Orebro, Sweden
- Orebro University Hospital, Department of General Surgery
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Stockholm, Sweden, SE-171
- Karolinska University Hospital
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Cambridge, United Kingdom, CB20QQ
- Addenbrooke's Hospital, Dept of Vascular Surgery
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London, United Kingdom, SW170QT
- St. George's Vascular Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male or female at least 18 years old
- Subject has signed informed consent for data release
- Subjects with AAA and eligible for endovascular repair
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Immediate procedural technical success
Time Frame: Procedure
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Number of subjects where immediate procedural technical success during procedure was noted
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Procedure
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Peri-operative Safety Parameters
Time Frame: Up to 30 days
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Number of subjects with procedural Blood loss >1000mL, Mortality (all-cause), Bowel Ischemia, Paraplegia, Renal Failure, Myocardial Infarction, Respiratory Failure, Stroke
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Up to 30 days
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Clinical outcome
Time Frame: Up to 5 years
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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)
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Up to 5 years
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Device Patency and Integrity
Time Frame: Up to 5 years
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Number of subjects with device patency and integrity throughout the study.
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Up to 5 years
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In-hospital evaluations
Time Frame: Discharge
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Evaluation of total amount of polymer fill, total endovascular time, anaesthesia time, fluoroscopy time, contrast volume used, total procedure time, estimated blood loss, incidence of transfusion, time in ICU, time to hospital discharge
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Discharge
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Distal Complications
Time Frame: 5 years
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Incidence of distal thrombosis, embolization and iliac stenosis.
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5 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Prof Andrew Holden, Auckland City Hospital
- Principal Investigator: Dr. Michel Reijnen, MD, Rijnstate Hospital, Arnhem NL
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CP0010-Ver. 1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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