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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02996396
|Contact: Frederick M Arbouremail@example.com|
|Contact: Sanae Horowitzfirstname.lastname@example.org|
|Principal Investigator:||Andrew Holden, MBChB||Auckland City Hospital|
|Principal Investigator:||Michel Reijnen, MD||Rijnstate, Arnhem, the Netherlands|