Safety and Performance of the Nellix Endovascular Sealing System Clinical Trial
— EVAS-FORWARD 1Official title:
Multicenter, Observational, Post-Market, Real World Registry to Assess Outcomes of Patients Treated With the Nellix® System for Endovascular Abdominal Aortic Aneurysm Repair
| Verified date | March 2022 |
| Source | Endologix |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Active, not recruiting |
| Enrollment | 300 |
| Est. completion date | June 30, 2022 |
| Est. primary completion date | September 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Klinikum Augsburg Klinik für Gefäßchirurgie | Augsburg | |
| Germany | Universitätsklinikum Düsseldorf Klinik für Gefäß- und Endovaskularchirurgie | Düsseldorf | |
| Germany | Alfried Krupp Krankenhaus Ruttenscheid, Vascular Centre | Essen | |
| Germany | Universitätsklinikum Heidelberg Klinik für Gefäßchirurgie Im Neuenheimer Feld | Heidelberg | |
| Germany | Klinikum Sud Nuernberg, Dept of Vascular Surgery | Nuernberg | |
| Germany | Klinikum Stuttgart Katharinenen Hospital | Stuttgart | |
| Latvia | Pauls Stadins Clinical University Hospital Riga | Riga | |
| Luxembourg | Hopital Kirchberg, Dept of Cardio-Vascular | Luxembourg-Kirchberg | |
| Netherlands | Academisch Medisch Centrum Amsterdam, Department of Surgery | Amsterdam | |
| Netherlands | Rijnstate Ziekenhuis, Vasculaire Centrum | Arnhem | |
| Netherlands | St Antonius Ziekenhuis, Dept of Vascular Surgery | Nieuwegein | |
| Netherlands | Erasmus Medical Centre, Dept of Vascular Surgery | Rotterdam | |
| Netherlands | St Elisabeth Ziekenhuis, Dept of Vascular Surgery | Tilburg | |
| New Zealand | Auckland City Hospital Interventional Radiology | Auckland | |
| Norway | Hospital Hamar | Hamar | |
| Sweden | Orebro University Hospital, Department of General Surgery | Orebro | |
| Sweden | Karolinska University Hospital | Stockholm | |
| United Kingdom | Addenbrooke's Hospital, Dept of Vascular Surgery | Cambridge | |
| United Kingdom | St. George's Vascular Institute | London |
| Lead Sponsor | Collaborator |
|---|---|
| Endologix |
Germany, Latvia, Luxembourg, Netherlands, New Zealand, Norway, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Device Patency and Integrity | Number of subjects with device patency and integrity throughout the study. | Up to 5 years | |
| Other | In-hospital evaluations | 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 | Discharge | |
| Other | Distal Complications | Incidence of distal thrombosis, embolization and iliac stenosis. | 5 years | |
| Primary | Immediate procedural technical success | Number of subjects where immediate procedural technical success during procedure was noted | Procedure | |
| Primary | 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 | |
| Primary | 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 |