Nellix Registry Study: EVAS-Global

NCT02996396 | Unknown

• 1 other identifier: CP0010 Ver. 2
• Study Type: observational
• Target: 300
• Locations: 4 countries
• Sites: 10

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)

Conditions

Abdominal Aortic Aneurysm

Keywords

AAA, Aortoiliac Aneurysm

Outcome Measures

Primary Outcomes (8)

• 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 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

• 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.

  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

Other Outcomes (2)

• Number of subjects with incidence of device patency and integrity

  5 years

• Number of incidence with Distal Complications

  5 years

Study Arms (1)

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.

Device: Nellix Endovascular Aneurysm Sealing System (Nellix®-System)

Interventions

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.

Also known as: Nellix EVAS FORWARD 2

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Endologix: lead

Study Sites (10)

Klinikum Augsburg Klinik für Gefäßchirurgie

Augsburg, 86156, Germany

Location

St. Marien Hospital Bonn

Bonn, 53115, Germany

Location

University Hospital Koeln

Cologne, 50937, Germany

Location

University Hospital Heidelberg

Heidelberg, 69120, Germany

Location

TUM Munich

Munich, 80333, Germany

Location

Rijnstate Hospital

Arnhem, 90, Netherlands

Location

St Elisabeth Ziekenhuis, Dept of Vascular Surgery

Tilburg, 5022 GC, Netherlands

Location

Auckland City Hospital

Auckland, New Zealand

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, 15006, Spain

Location

Hospital Universitario y Politécnico de La Fe

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Andrew Holden, MBChB

  Auckland City Hospital

  PRINCIPAL INVESTIGATOR

• Michel Reijnen, MD

  Rijnstate, Arnhem, the Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: December 19, 2016
• Study Start: November 1, 2016
• Primary Completion: November 21, 2023
• Study Completion: November 1, 2024
• Last Updated: June 7, 2022

Record last verified: 2022-06

Locations

NL (2); DE (5); ES (2); NZ (1)