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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nellix Endovascular Aneurysm Sealing System (Nellix®-System) | Device | The Nellix system is comprised of two independent flow channels, one to each iliac artery. Each flow channel consists of a balloon-expanded ePTFE covered stent surrounded by a Polymer-filled EndoBag which fills the blood lumen within the aorta, and seals the aneurysm from side-branch flow. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with Immediate Procedural Technical Success | Technical success is defined as successful delivery and deployment of the Nellix System in the planned location. | 30 Days |
| Safety assessment by Number of subjects with absence of Major Adverse Events (MAEs) | Safety endpoint is measured with the number of subjects who are reported freedom 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. | 30 Days |
| Number of subjects with Aneurysm rupture | 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). | 5 years |
| Number of subjects with Conversion to open surgical repair | 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). | 5 years |
| Number of subjects with Endoleak of any type | 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. | 5 years |
| Number of subjects with Clinically significant migration | The number of patients with clinically significant migration will be summarized descriptively. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with incidence of device patency and integrity | Device patency and integrity will be measured by the number and proportion of patients at 30 days, 6 months, and 1 year to 5 years including Stent Kinking, Lumen Occlusion, and Stent Fracture. | 5 years |
| Number of incidence with Distal Complications |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Holden, MBChB | Auckland City Hospital | Principal Investigator |
| Michel Reijnen, MD | Rijnstate, Arnhem, the Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Augsburg Klinik für Gefäßchirurgie | Augsburg | 86156 | Germany | |||
| St. Marien Hospital Bonn |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 5 years |
| Number of subjects with Aneurysm enlargement | 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. | 5 years |
| Number of incidence with Secondary endovascular procedures | The overall secondary procedure incidence and the individual component incidence will be provided. | 5 years |
The number of incidence of distal thrombosis, embolization and iliac stenosis will be summarized. |
| 5 years |
| Bonn |
| 53115 |
| Germany |
| University Hospital Koeln | Cologne | 50937 | Germany |
| University Hospital Heidelberg | Heidelberg | 69120 | Germany |
| TUM Munich | Munich | 80333 | Germany |
| Rijnstate Hospital | Arnhem | 90 | Netherlands |
| St Elisabeth Ziekenhuis, Dept of Vascular Surgery | Tilburg | 5022 GC | Netherlands |
| Auckland City Hospital | Auckland | New Zealand |
| Complejo Hospitalario Universitario A Coruña | A Coruña | 15006 | Spain |
| Hospital Universitario y Politécnico de La Fe | Valencia | 46026 | Spain |
| D001018 |
| Aortic Diseases |