Nellix Registry Study: EVAS-Global

Abdominal Aortic Aneurysm Clinical Trial

— EVAS FORWARD 2  

Official title:

Multicenter, Observational, Registry to Assess Outcomes of Patients Treated With the CE Marked Nellix® System for Endovascular Abdominal Aortic Aneurysm Repair"

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02996396
• Other study ID #: CP0010 Ver. 2
• Status: Active, not recruiting
• Start date: November 2016
• Est. completion date: November 2024

Study information

• Verified date: June 2022
• Source: Endologix
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: November 2024
• Est. primary completion date: November 21, 2023
• 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 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)

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

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.

Locations

Country	Name	City	State
Germany	Klinikum Augsburg Klinik für Gefäßchirurgie	Augsburg
Germany	St. Marien Hospital Bonn	Bonn
Germany	University Hospital Heidelberg	Heidelberg
Germany	University Hospital Koeln	Koeln
Germany	TUM Munich	Munich
Netherlands	Rijnstate Hospital	Arnhem
Netherlands	St Elisabeth Ziekenhuis, Dept of Vascular Surgery	Tilburg
New Zealand	Auckland City Hospital	Auckland
Spain	Complejo Hospitalario Universitario A Coruña	A Coruña
Spain	Hospital Universitario y Politécnico de La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Endologix

Countries where clinical trial is conducted

Germany,  Netherlands,  New Zealand,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Number of incidence with Distal Complications	The number of incidence of distal thrombosis, embolization and iliac stenosis will be summarized.	5 years
Primary	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
Primary	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 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.	30 Days
Primary	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
Primary	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
Primary	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
Primary	Number of subjects with Clinically significant migration	The number of patients with clinically significant migration will be summarized descriptively.	5 years
Primary	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
Primary	Number of incidence with Secondary endovascular procedures	The overall secondary procedure incidence and the individual component incidence will be provided.	5 years