Nellix Registry Study: EVAS-Global
- Conditions
- Abdominal Aortic Aneurysm
- Interventions
- Device: Nellix Endovascular Aneurysm Sealing System (Nellix®-System)
- Registration Number
- NCT02996396
- Lead Sponsor
- Endologix
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- Male or female at least 18 years old
- Subject has signed informed consent for data release
- Subjects with with AAA and eligible for endovascular repair
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 Nellix Endovascular Aneurysm Sealing System (Nellix®-System) 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.
- Primary Outcome Measures
Name Time Method Safety assessment by Number of subjects with absence of Major Adverse Events (MAEs) 30 Days Safety endpoint is measured with the number of subjects who are reported freedome of major adverse events (MAEs) including (1) all-cause death, (2) bowel ischemia, (3) myocardial infarction, (4) paraplegia, (5) renal failure, (6) respiratory failure, (7) stroke, and (8) Blood Loss \> 1000mL at 30 Days post index procedure.
Number of subjects with Immediate Procedural Technical Success 30 Days Technical success is defined as successful delivery and deployment of the Nellix System in the planned location.
Number of subjects with Conversion to open surgical repair 5 years The number of patients undergoing surgical conversion to open repair will be provided at 30 days and within each follow-up window (i.e., six months, and annually at years 1 through 5).
Number of subjects with Clinically significant migration 5 years The number of patients with clinically significant migration will be summarized descriptively.
Number of incidence with Secondary endovascular procedures 5 years The overall secondary procedure incidence and the individual component incidence will be provided.
Number of subjects with Aneurysm rupture 5 years The number of patients experiencing a rupture of the aneurysm will be summarized at 30 days and within each follow-up window (i.e., six months, and annually at years 1 through 5).
Number of subjects with Aneurysm enlargement 5 years The number of patients with Aneurysm enlargement will be summarized descriptively. Sac enlargement is defined in the protocol as increase in late follow-up compared to the initial post-op measurement.
Number of subjects with Endoleak of any type 5 years The number of patients with any endoleak, and patients with each endoleak type at 30 days and within each follow-up window (i.e., six months, and annually at years 1 through 5) will be summarized.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
St. Marien Hospital Bonn
🇩🇪Bonn, Germany
Klinikum Augsburg Klinik für Gefäßchirurgie
🇩🇪Augsburg, Germany
University Hospital Heidelberg
🇩🇪Heidelberg, Germany
University Hospital Koeln
🇩🇪Koeln, Germany
Rijnstate Hospital
🇳🇱Arnhem, Netherlands
TUM Munich
🇩🇪Munich, Germany
St Elisabeth Ziekenhuis, Dept of Vascular Surgery
🇳🇱Tilburg, Netherlands
Auckland City Hospital
🇳🇿Auckland, New Zealand
Complejo Hospitalario Universitario A Coruña
🇪🇸A Coruña, Spain
Hospital Universitario y Politécnico de La Fe
🇪🇸Valencia, Spain