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The Nellix® EndoVascular Aneurysm Sealing System for the Treatment of Infrarenal Abdominal Aortic Aneurysms

Primary Purpose

Abdominal Aortic Aneurysms

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

The Nellix® EndoVascular Aneurysm Sealing System

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysms focused on measuring Aortic Aneurysm, Abdominal, Endovascular Procedures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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;
1. aneurysm ≥ 4.5 cm in diameter, or
2. aneurysm is twice the diameter of the normal infrarenal aorta, or
3. 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

Exclusion Criteria:

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)
Patient is pregnant or nursing
Patient is currently enrolled in an investigational drug or device trial

Sites / Locations

Centro Medico de Cali
Paul Stradins University Hospital
Auckland City Hospital
Instituto de Clinicas Y Urologica Tomanaco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nellix Aneurysm Sealing

Arm Description

The Nellix® EndoVascular Aneurysm Sealing System

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

All Cause Mortality

Any death occurring during the study period, regardless of cause

Full Information

NCT ID

NCT02048514

First Posted

January 27, 2014

Last Updated

March 5, 2021

Sponsor

Endologix

1. Study Identification

Unique Protocol Identification Number

NCT02048514

Brief Title

The Nellix® EndoVascular Aneurysm Sealing System for the Treatment of Infrarenal Abdominal Aortic Aneurysms

Official Title

The Nellix® EndoVascular Aneurysm Sealing System for the Treatment of Infrarenal Abdominal Aortic Aneurysms

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Endologix

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This is a multicenter, multi-country prospective, single-arm, non-randomized clinical trial. The comparative control arm is a combination of patient data drawn from the abdominal aortic aneurysms (AAA) open surgical control arms of four commercially approved AAA devices as part of the Society of Vascular Surgeons. Patients enrolled in this study will be pre-screened and have a diagnosis of an infrarenal AAA with or without the need for treatment of iliac artery aneurysm, are candidates for endovascular repair, and meet the eligibility criteria. Patients enrolled in the study will participate in follow-up visits 31 days, 6 months and at 1 year following the index procedure. At the follow-up visits there will be a clinical assessment, blood collection, and abdominal CT imaging of the patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Abdominal Aortic Aneurysms

Keywords

Aortic Aneurysm, Abdominal, Endovascular Procedures

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

69 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nellix Aneurysm Sealing

Arm Type

Experimental

Arm Description

The Nellix® EndoVascular Aneurysm Sealing System

Intervention Type

Device

Intervention Name(s)

The Nellix® EndoVascular Aneurysm Sealing System

Primary Outcome Measure Information:

Title

Safety- Number of Major Adverse Events

Description

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

Time Frame

30 day

Title

Device Performance

Description

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.

Time Frame

30 days

Secondary Outcome Measure Information:

Title

All Cause Mortality

Description

Any death occurring during the study period, regardless of cause

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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) Patient is pregnant or nursing Patient is currently enrolled in an investigational drug or device trial

Facility Information:

Facility Name

Centro Medico de Cali

City

Cali

ZIP/Postal Code

24-157

Country

Colombia

Facility Name

Paul Stradins University Hospital

City

Riga

ZIP/Postal Code

LV-1007

Country

Latvia

Facility Name

Auckland City Hospital

City

Auckland

ZIP/Postal Code

1142

Country

New Zealand

Facility Name

Instituto de Clinicas Y Urologica Tomanaco

City

Caracas

Country

Venezuela

12. IPD Sharing Statement

Learn more about this trial

The Nellix® EndoVascular Aneurysm Sealing System for the Treatment of Infrarenal Abdominal Aortic Aneurysms

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