NCT03298477 (EVAS2) is a NA clinical trial of Nellix® System in Abdominal Aortic Aneurysm Without Rupture, sponsored by Endologix.

Who is sponsoring NCT03298477?

NCT03298477 is sponsored by Endologix.

What drugs are being tested in NCT03298477?

Interventions in NCT03298477: Nellix® System.

What condition does NCT03298477 study?

NCT03298477 studies Abdominal Aortic Aneurysm Without Rupture.

Is NCT03298477 still recruiting?

NCT03298477 is currently active, enrolled. Last updated 19 March 2025.

Are results published for NCT03298477?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-03-19 · How we verify

NCT03298477: EVAS2

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study

Active, enrolled NA Results posted Last updated 19 March 2025

What this trial tests

NA trial testing Nellix® System in Abdominal Aortic Aneurysm Without Rupture in 98 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 December 2017

Primary endpoint
7 June 2022

16 August 2025

Quick facts

Lead sponsor	Endologix
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	98
Start date	1 December 2017
Primary completion	7 June 2022
Estimated completion	16 August 2025
Sites	27 locations across United States

Drugs / interventions tested

Nellix® System

Conditions studied

Abdominal Aortic Aneurysm Without Rupture — all drugs for Abdominal Aortic Aneurysm Without Rupture →

Sponsor

Endologix

Who can join

18 and older, any sex, with Abdominal Aortic Aneurysm Without Rupture. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Safety: Major Adverse Events (MAE) Primary · 30 days

The primary safety endpoint is defined as the incidence of Major Adverse Events (MAE) at 30 days, defined as the composite of the following All-Cause Mortality; Bowel Ischemia; Myocardial Infarction; Paraplegia; Renal Failure; Respiratory Failure; Stroke; Procedural Blood Loss ≥1,000cc

Death

Group	Value	95% CI
Nellix System	1

Myocardial Infarction

Group	Value	95% CI
Nellix System	2

Renal Failure

Group	Value	95% CI
Nellix System	2

Effectiveness: Rate of Treatment Success Primary · 2 year

The primary effectiveness endpoint is defined as the rate of Treatment Success at year 2. Treatment Success is a composite of outcomes clinically relevant to the endovascular repair of infrarenal AAA as follows: It is defined as procedural technical success and absence of Abdominal aortic aneurysm rupture; Conversion to open surgical repair; Endoleak Type I or III at year 2; Clinically significant migration; \> 5mm aneurysm sac enlargement of the maximal diameter as measured by the difference from the 30-Day CT time point; or Secondary endovascular procedure up to year 2 for resolution of End

Group	Value	95% CI
Nellix System	92.2

Conversions, Death and Ruptures Secondary · 2 Years

Number of Deaths, Conversion and ruptures through the data cut of the July 7, 2023,

Conversion

Group	Value	95% CI
Nellix EndoVascular Aneurysm Sealing System	0

Deaths

Group	Value	95% CI
Nellix EndoVascular Aneurysm Sealing System	7

Ruptures

Group	Value	95% CI
Nellix EndoVascular Aneurysm Sealing System	0

Device Integrity Secondary · 2 Years

Device Integrity is defined as the absence of device fracture, stenosis, kink, occlusion, or migration \>5mm. All incidences of stent occlusion (100% device lumen obstruction) are also captured as stent stenosis (\<100% device lumen obstruction).

Stenosis

Group	Value	95% CI
Nellix EndoVascular Aneurysm Sealing System:	5

Stent Occlusion

Group	Value	95% CI
Nellix EndoVascular Aneurysm Sealing System:	4

Migration>5mm

Group	Value	95% CI
Nellix EndoVascular Aneurysm Sealing System:	1

Migration >10mm

Group	Value	95% CI
Nellix EndoVascular Aneurysm Sealing System:	0

Stent Kinking

Group	Value	95% CI
Nellix EndoVascular Aneurysm Sealing System:	0

Stent Fracture

Group	Value	95% CI
Nellix EndoVascular Aneurysm Sealing System:	0

Device Performance - Endoleak Secondary · 2 Years

Demonstrates device performance as indicated by the incidence of Endoleaks through study follow-up. Endoleak is determined by the CoreLab based on imaging completed. Endoleak is defined as clear evidence of contrast outside of one or both EndoBags which communicates with the aneurysm sac originating proximally at the infrarenal segment (Type IA), distally (Type IB); between components, if an extender is used (Type III); trans-device (Type IV); or from a patent collateral vessel (Type II: e.g., lumbar artery; inferior mesenteric artery).

Endoleak Type IA

Group	Value	95% CI
Single Arm Nellix EndoVascular Aneurysm Sealing System	5

Endoleak Type IB

Group	Value	95% CI
Single Arm Nellix EndoVascular Aneurysm Sealing System	1

Endoleak Type II

Group	Value	95% CI
Single Arm Nellix EndoVascular Aneurysm Sealing System	6

Endoleak Type III

Group	Value	95% CI
Single Arm Nellix EndoVascular Aneurysm Sealing System	0

Endoleak Type IV

Group	Value	95% CI
Single Arm Nellix EndoVascular Aneurysm Sealing System	0

Endoleak Unknown

Group	Value	95% CI
Single Arm Nellix EndoVascular Aneurysm Sealing System	1

DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Avg Size Secondary · 2 years

Average Sac Diameter size at Visit

Group	Value	95% CI
Nellix System	55.4	± 5.9

DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Changes in Sac Size Since 01 Month Secondary · 2 Years

Number of subjects that had changes in the Sac Diameter size since the 1 month follow-up visit

Decreased >5mm

Group	Value	95% CI
Nellix System	3

Stable +- 5mm

Group	Value	95% CI
Nellix System	69

Increased >5mm

Group	Value	95% CI
Nellix System	4

No Growth

Group	Value	95% CI
Nellix System	72

Secondary Interventions Secondary · 2 Years

All Secondary interventions reported during the study

Conversion to open repair due to aneurysm expansion

Group	Value	95% CI
Nellix System	0

Iliac Extension due to aneurysm expansion

Group	Value	95% CI
Nellix System	1

Iliac Stenting due to renal failure

Group	Value	95% CI
Nellix System	1

Renal stent due to renal failure

Group	Value	95% CI
Nellix System	1

Iliac Extension due to Vessel Dissection (Non aortic)

Group	Value	95% CI
Nellix System	1

Thrombolysis due to Vessel Dissection (Non aortic)

Group	Value	95% CI
Nellix System	1

Conversion to Open Repair due to endoleak IA

Group	Value	95% CI
Nellix System	0

Coil Embolization due to Endoleak II

Group	Value	95% CI
Nellix System	1

LABS-RENAL FUNCTION (EGFR) Secondary · 2 Years

The outcome demonstrates the protocol specified laboratory values (collected as eGFR) captured at each follow-up visit

Group	Value	95% CI
Nellix System	66	± 24

LABS- RENAL FUNCTION (CREATININE) Secondary · 2 Years

Labs- Renal Function demonstrates the protocol specified laboratory values (Collected as creatinine) captured at each follow-up visit

Group	Value	95% CI
Nellix System	1.19	± 0.42

Adverse events — posted to ClinicalTrials.gov

Time frame: All Adverse Events data occurring during the study period were collected (i.e. procedure through 5 years follow-up). The data reported here are as of the data cut for 2-year primary endpoint data.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Single Arm Nellix EndoVascular Aneurysm Sealing System

Serious: 49/98 (50%)

Deaths: 7/98

Serious adverse events (13 terms)

Reaction	System	Single Arm Nellix EndoVasc…
Miscellaneous	General disorders	—
Cardiac	Cardiac disorders	—
Pulmonary	Respiratory, thoracic and mediastinal disorders	—
Renal	Renal and urinary disorders	—
Bleeding/Anemia	Blood and lymphatic system disorders	—
Malignancies	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Neurological	Nervous system disorders	—
Urogenital	Renal and urinary disorders	—
Bowel	Gastrointestinal disorders	—
Nellix Device	Product Issues	—
Vascular	Vascular disorders	—
Surgical Site Wound	Surgical and medical procedures	—
Chimney Device	Surgical and medical procedures	—

Other adverse events (13 terms — click to expand)

Reaction	System	Single Arm Nellix EndoVasc…
Miscellaneous	General disorders	—
Urogenital	Renal and urinary disorders	—
Cardiac	Cardiac disorders	—
Renal	Renal and urinary disorders	—
Malignancies	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Vascular	Vascular disorders	—
Bowel	Gastrointestinal disorders	—
Nellix Device	Product Issues	—
Neurological	Nervous system disorders	—
Surgical Site Wound	Surgical and medical procedures	—
Bleeding/Anemia	Blood and lymphatic system disorders	—
Chimney Device	Respiratory, thoracic and mediastinal disorders	—
Pulmonary	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Miscellaneous, Cardiac, Pulmonary, Renal, Bleeding/Anemia, Malignancies, Neurological, Urogenital.

Data from ClinicalTrials.gov NCT03298477 adverse events section.

Sponsor's own description

Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Systematic Review on the Mid-Term Outcomes of Elective Endovascular Aneurysm Sealing in Comparison to Endovascular Aneurysm Repair.
Zoethout AC, Hochstenbach I, van der Laan MJ, de Vries JPM, et al · · 2022 · cited 7× · PMID 34569337 · DOI 10.1177/15266028211047941

Verify or expand the search:

Other recruiting trials for Abdominal Aortic Aneurysm Without Rupture

Currently open trials in the same condition.

NCT06332911 — Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair · recruiting
NCT06866769 — Efficacy of Biomarkers and CEUS Versus CTA in AAA Follow-up Post-EVAR · recruiting
NCT04894864 — Opioid Free Anesthesia-Analgesia Strategy and Surgical Stress in Elective Open Abdominal Aortic Aneurysm Repair · Phase 4 · recruiting

Other Endologix trials

Trials by the same sponsor.

NCT06315023 — The Percutaneous Transmural Arterial Bypass -1 Study (Post Approval Registry) · recruiting
NCT04625660 — Detour2 Continued Access Study · NA · completed
NCT04130737 — TORUS 2 IDE Clinical Study · NA · active not recruiting
NCT03119233 — The DETOUR 2 Clinical Trial · NA · completed
NCT02949297 — Expanding Patient Applicability With Polymer Sealing Ovation Alto Stent Graft Investigational Device Exemption (IDE) Stu · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03298477 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Endologix
Last refreshed: 19 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03298477.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing