Overview

This trial is active, not recruiting.

Condition abdominal aortic aneurysms
Treatment the nellix® endovascular aneurysm sealing system
Sponsor Endologix
Start date December 2008
End date January 2014
Trial size 69 participants
Trial identifier NCT02048514, N09-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
The Nellix® EndoVascular Aneurysm Sealing System
the nellix® endovascular aneurysm sealing system

Primary Outcomes

Measure
Safety
time frame: 30 day
Device Performance
time frame: 30 days

Secondary Outcomes

Measure
All Cause Mortality
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title The Nellix® EndoVascular Aneurysm Sealing System for the Treatment of Infrarenal Abdominal Aortic Aneurysms
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Endologix.