Nellix Registry Study: EVAS-Global (EVAS FORWARD 2)
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|ClinicalTrials.gov Identifier: NCT02996396|
Recruitment Status : Recruiting
First Posted : December 19, 2016
Last Update Posted : December 19, 2016
|Condition or disease||Intervention/treatment|
|Abdominal Aortic Aneurysm||Device: Nellix Endovascular Aneurysm Sealing System (Nellix®-System)|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||300 participants|
|Target Follow-Up Duration:||60 Months|
|Official Title:||Multicenter, Observational, Registry to Assess Outcomes of Patients Treated With the CE Marked Nellix® System for Endovascular Abdominal Aortic Aneurysm Repair"|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||October 2023|
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.
Device: Nellix Endovascular Aneurysm Sealing System (Nellix®-System)
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.
Other Name: Nellix EVAS FORWARD 2
- Number of subjects with Immediate Procedural Technical Success [ Time Frame: 30 Days ]Technical success is defined as successful delivery and deployment of the Nellix System in the planned location.
- Safety assessment by Number of subjects with absence of Major Adverse Events (MAEs) [ Time Frame: 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 Aneurysm rupture [ Time Frame: 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 Conversion to open surgical repair [ Time Frame: 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 Endoleak of any type [ Time Frame: 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.
- Number of subjects with Clinically significant migration [ Time Frame: 5 years ]The number of patients with clinically significant migration will be summarized descriptively.
- Number of subjects with Aneurysm enlargement [ Time Frame: 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 incidence with Secondary endovascular procedures [ Time Frame: 5 years ]The overall secondary procedure incidence and the individual component incidence will be provided.
- Number of incidence with Distal Complications [ Time Frame: 5 years ]The number of incidence of distal thrombosis, embolization and iliac stenosis will be summarized.
- Number of subjects with incidence of device patency and integrity [ Time Frame: 5 years ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02996396
|Contact: Frederick M Arbourfirstname.lastname@example.org|
|Contact: Sanae Horowitzemail@example.com|
|Auckland City Hospital||Recruiting|
|Auckland, New Zealand|
|Contact: Andrew Holden, MBChB AndrewH@adhb.govt.nz|
|Contact: Helen Knight HKnight@adhb.govt.nz|
|Principal Investigator:||Andrew Holden, MBChB||Auckland City Hospital|
|Principal Investigator:||Michel Reijnen, MD||Rijnstate, Arnhem, the Netherlands|