NCT02048514

Brief Summary

The purpose of this clinical study is to evaluate the safety and device performance of the Nellix® EndoVascular Aneurysm Sealing System (Nellix System) for the treatment of infrarenal abdominal aortic aneurysms.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2008

Longer than P75 for not_applicable

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 29, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

9 years

First QC Date

January 27, 2014

Last Update Submit

March 5, 2021

Conditions

Abdominal Aortic Aneurysms

Keywords

Aortic Aneurysm, AbdominalEndovascular Procedures

Outcome Measures

Primary Outcomes (2)

  • Safety- Number of Major Adverse Events

    The primary safety endpoint is defined as the incidence of Major Adverse Events (MAE) through 30 days after the index procedure.

    30 day

  • Device Performance

    The primary performance endpoint is technical success defined as successful delivery and deployment of the device and freedom from open surgical conversion at 30 days.

    30 days

Secondary Outcomes (1)

  • All Cause Mortality

    12 months

Study Arms (1)

Nellix Aneurysm Sealing

EXPERIMENTAL

The Nellix® EndoVascular Aneurysm Sealing System

Device: The Nellix® EndoVascular Aneurysm Sealing System

Interventions

The Nellix® EndoVascular Aneurysm Sealing SystemDEVICE
Nellix Aneurysm Sealing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years of age
  • Informed consent form understood and signed and patient agrees to all follow-up visits
  • Is able and willing to comply with clinical follow-up requirements for one year
  • Is able and willing to undergo Contrast-Enhanced Spiral CT scans
  • Is a candidate for endovascular repair of an infrarenal aortic aneurysm with or without an iliac aneurysm with at least one of the following;
  • aneurysm ≥ 4.5 cm in diameter, or
  • aneurysm is twice the diameter of the normal infrarenal aorta, or
  • aneurysm is growing at a rate of ≥ 10 % per year
  • Non-aneurysmal aortic neck length ≥ 5mm below the most inferior renal artery
  • Proximal aortic neck diameter between 16 and 36mm
  • Aortic neck angulation to the sac ≤ 60
  • Common iliac artery diameter 8 to 35mm bilaterally
  • Aneurysm blood lumen diameter ≤ 60mm
  • Iliac and femoral arteries suitable for endovascular access with the Nellix System

You may not qualify if:

  • Life expectancy ≤ 1 year
  • Dissecting, ruptured, or leaking aneurysm (blood outside the aorta), has sustained recent trauma, is symptomatic, or is non-degenerative
  • Aneurysm is thoraco-abdominal, suprarenal and/or mycotic
  • Thoracic aneurysm ≥ 4.5cm in diameter
  • AAA requires treatment that would result in bilateral occlusion of the internal iliac arteries
  • Presence of mural thrombus \> 50% circumferentially in aortic neck
  • Iliac aneurysm blood lumen diameter \> 35mm
  • Active infection, vasculitis, or systemic connective tissue disease (e.g., Rheumatoid arthritis, scleroderma, Marfan's syndrome, Ehlers-Danlos disease) at time of procedure
  • History of prior treatment of abdominal aortic or iliac artery aneurysm disease
  • Femoral or iliac artery occlusive disease such that device delivery is not possible
  • Vascular access for delivery of device requires placement of vascular conduit or is through an established vascular graft
  • Receiving dialysis
  • History of hypercoagulability
  • Allergy to IV contrast
  • Serum creatinine level \>2.0 mg/dL (or equivalent)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Centro Medico de Cali

Cali, 24-157, Colombia

Location

Paul Stradins University Hospital

Riga, LV-1007, Latvia

Location

Auckland City Hospital

Auckland, 1142, New Zealand

Location

Instituto de Clinicas Y Urologica Tomanaco

Caracas, Venezuela

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2014

First Posted

January 29, 2014

Study Start

December 1, 2008

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 9, 2021

Record last verified: 2021-03

Locations

NZ(1)VE(1)CO(1)LA(1)