Trial Outcomes & Findings for EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study (NCT NCT03298477)

NCT ID: NCT03298477

Last Updated: 2025-03-19

Results Overview

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

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 98 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2025-03-19

Participant Flow

Participant milestones

Measure	Single Arm Nellix EndoVascular Aneurysm Sealing System Nellix EndoVascular Aneurysm Sealing System: The study is designed to evaluate the safety, effectiveness and performance of the Nellix System for endovascular aneurysm repair. Subjects will be followed procedurally to discharge, at 30 days (primary safety endpoint), six months, one year, two year (primary effectiveness endpoint) and annually thereafter to five years (total follow-up commitment).
1 Month Follow-Up STARTED	98
1 Month Follow-Up COMPLETED	97
1 Month Follow-Up NOT COMPLETED	1
6 Month Follow-Up STARTED	97
6 Month Follow-Up COMPLETED	93
6 Month Follow-Up NOT COMPLETED	4
1 Year Follow-Up STARTED	93
1 Year Follow-Up COMPLETED	91
1 Year Follow-Up NOT COMPLETED	2
2 Year Follow-Up STARTED	91
2 Year Follow-Up COMPLETED	81
2 Year Follow-Up NOT COMPLETED	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Single Arm Nellix EndoVascular Aneurysm Sealing System n=97 Participants All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System. The study is designed to evaluate the safety, effectiveness and performance of the Nellix System for endovascular aneurysm repair. Subjects will be followed procedurally to discharge, at 30 days (primary safety endpoint), six months, one year, two years (primary effectiveness endpoint) and annually thereafter to five years (total follow-up commitment).
Age, Continuous	73 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	86 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	89 Participants n=5 Participants
Race/Ethnicity, Customized Non Caucasian	8 Participants n=5 Participants
Region of Enrollment United States	97 participants n=5 Participants
Height	177 cm STANDARD_DEVIATION 10 • n=5 Participants
ASA Class (ASA Physical Status Classification System) ASA Class 1/2	32 Participants n=5 Participants
ASA Class (ASA Physical Status Classification System) ASA Class 3/4/5	65 Participants n=5 Participants
SVS Class (Society for Vascular Surgery Classification System) SVS/AAVS comorbidity score SVS Score: 0/1	93 Participants n=5 Participants
SVS Class (Society for Vascular Surgery Classification System) SVS/AAVS comorbidity score SVS Score: 2/3/4	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: 98 patients enrolled under the study

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

Outcome measures

Measure	Nellix System n=98 Participants Single Arm Safety and Effectiveness Confirmatory Study of EVAS using the Nellix® System Nellix® System: Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System
Safety: Major Adverse Events (MAE) Death	1 Number of Events
Safety: Major Adverse Events (MAE) Myocardial Infarction	2 Number of Events
Safety: Major Adverse Events (MAE) Renal Failure	2 Number of Events

PRIMARY outcome

Timeframe: 2 year

Population: Only 77 subjects completed study related procedures at 2 year time point.

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 Endoleak (Type I or Type III), Device obstruction or occlusion, Device migration, Abdominal aneurysm sac expansion, Device defect.

Outcome measures

Measure	Nellix System n=77 Participants Single Arm Safety and Effectiveness Confirmatory Study of EVAS using the Nellix® System Nellix® System: Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System
Effectiveness: Rate of Treatment Success	92.2 percentage of treatment success

SECONDARY outcome

Timeframe: 2 Years

Population: 93 subjects that completed their 2 year visit as of the data cut off of 07Jul2023

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

Outcome measures

Measure	Nellix System n=93 Participants Single Arm Safety and Effectiveness Confirmatory Study of EVAS using the Nellix® System Nellix® System: Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System
Conversions, Death and Ruptures Ruptures	0 Number of Events
Conversions, Death and Ruptures Conversion	0 Number of Events
Conversions, Death and Ruptures Deaths	7 Number of Events

SECONDARY outcome

Timeframe: 2 Years

Population: 75 participants that were analyzed for device integrity as of 07Jul2023, Data for \>5mm Migration includes subjects with Migration \>10mm as well.

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).

Outcome measures

Measure	Nellix System n=75 Participants Single Arm Safety and Effectiveness Confirmatory Study of EVAS using the Nellix® System Nellix® System: Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System
Device Integrity Stenosis	5 Number of Events
Device Integrity Stent Occlusion	4 Number of Events
Device Integrity Migration>5mm	1 Number of Events
Device Integrity Migration >10mm	0 Number of Events
Device Integrity Stent Kinking	0 Number of Events
Device Integrity Stent Fracture	0 Number of Events

SECONDARY outcome

Timeframe: 2 Years

Population: 75 subjects analyzed for Endoleaks at 2 years as of the data cut-off date of 07Jul2023

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).

Outcome measures

Measure	Nellix System n=75 Participants Single Arm Safety and Effectiveness Confirmatory Study of EVAS using the Nellix® System Nellix® System: Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System
Device Performance - Endoleak Endoleak Type IA	5 Participants
Device Performance - Endoleak Endoleak Type IB	1 Participants
Device Performance - Endoleak Endoleak Type II	6 Participants
Device Performance - Endoleak Endoleak Type III	0 Participants
Device Performance - Endoleak Endoleak Type IV	0 Participants
Device Performance - Endoleak Endoleak Unknown	1 Participants

SECONDARY outcome

Timeframe: 2 years

Population: 76 Subjects that were analyzed at 2 years for Average Sac size in diameters as of the data cut-off date of 07Jul2023

Average Sac Diameter size at Visit

Outcome measures

Measure	Nellix System n=76 Participants Single Arm Safety and Effectiveness Confirmatory Study of EVAS using the Nellix® System Nellix® System: Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System
DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Avg Size	55.4 mm Standard Deviation 5.9

SECONDARY outcome

Timeframe: 2 Years

Population: 76 Subjects that were analyzed at 2 years for changes in Diameter sac Changes since 1month as of the cutoff date of 07Jul2023

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

Outcome measures

Measure	Nellix System n=76 Participants Single Arm Safety and Effectiveness Confirmatory Study of EVAS using the Nellix® System Nellix® System: Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System
DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Changes in Sac Size Since 01 Month Decreased >5mm	3 Number of subjects
DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Changes in Sac Size Since 01 Month Stable +- 5mm	69 Number of subjects
DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Changes in Sac Size Since 01 Month Increased >5mm	4 Number of subjects
DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Changes in Sac Size Since 01 Month No Growth	72 Number of subjects

SECONDARY outcome

Timeframe: 2 Years

Population: 93 subjects analyzed for the number of secondary interventions

All Secondary interventions reported during the study

Outcome measures

Measure	Nellix System n=93 Participants Single Arm Safety and Effectiveness Confirmatory Study of EVAS using the Nellix® System Nellix® System: Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System
Secondary Interventions Conversion to Open Repair due to endoleak IA	0 Number of Events
Secondary Interventions Conversion to open repair due to aneurysm expansion	0 Number of Events
Secondary Interventions Iliac Extension due to aneurysm expansion	1 Number of Events
Secondary Interventions Iliac Stenting due to renal failure	1 Number of Events
Secondary Interventions Renal stent due to renal failure	1 Number of Events
Secondary Interventions Iliac Extension due to Vessel Dissection (Non aortic)	1 Number of Events
Secondary Interventions Thrombolysis due to Vessel Dissection (Non aortic)	1 Number of Events
Secondary Interventions Coil Embolization due to Endoleak II	1 Number of Events
Secondary Interventions Thrombolysis due to Stent Thrombosis	2 Number of Events
Secondary Interventions Stent relining due to Stent Thrombosis	1 Number of Events
Secondary Interventions Fem-Fem Bypass due to Stent Thrombosis	1 Number of Events
Secondary Interventions Conversion to Open Repair due to stent migration	0 Number of Events
Secondary Interventions Renal stent due to Renal Artery Occlusion	1 Number of Events

SECONDARY outcome

Timeframe: 2 Years

Population: 80 subjects analyzed for renal function (eGFR) at 2 years as of the data cut-off date of 07Jul2023

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

Outcome measures

Measure	Nellix System n=80 Participants Single Arm Safety and Effectiveness Confirmatory Study of EVAS using the Nellix® System Nellix® System: Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System
LABS-RENAL FUNCTION (EGFR)	66 mL/min/1.73 m^2 Standard Deviation 24

SECONDARY outcome

Timeframe: 2 Years

Population: 80 subjects analyzed for renal function (Creatinine) at 2 years as of the data cut-off date of 07Jul2023

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

Outcome measures

Measure	Nellix System n=80 Participants Single Arm Safety and Effectiveness Confirmatory Study of EVAS using the Nellix® System Nellix® System: Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System
LABS- RENAL FUNCTION (CREATININE)	1.19 mg/dL Standard Deviation 0.42

Adverse Events

Single Arm Nellix EndoVascular Aneurysm Sealing System

Serious events: 49 serious events

Other events: 22 other events

Deaths: 7 deaths

Serious adverse events

Measure	Single Arm Nellix EndoVascular Aneurysm Sealing System n=98 participants at risk Nellix EndoVascular Aneurysm Sealing System: The study is designed to evaluate the safety, effectiveness and performance of the Nellix System for endovascular aneurysm repair. Subjects will be followed procedurally to discharge, at 30 days (primary safety endpoint), six months, one year, two year (primary effectiveness endpoint) and annually thereafter to five years (total follow-up commitment).
Blood and lymphatic system disorders Bleeding/Anemia	5.1% 5/98 • Number of events 5 • 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.
Gastrointestinal disorders Bowel	4.1% 4/98 • Number of events 4 • 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.
Cardiac disorders Cardiac	11.2% 11/98 • Number of events 13 • 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.
Surgical and medical procedures Chimney Device	0.00% 0/98 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignancies	5.1% 5/98 • Number of events 5 • 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.
General disorders Miscellaneous	19.4% 19/98 • Number of events 20 • 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.
Product Issues Nellix Device	4.1% 4/98 • Number of events 6 • 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.
Nervous system disorders Neurological	5.1% 5/98 • Number of events 5 • 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.
Respiratory, thoracic and mediastinal disorders Pulmonary	8.2% 8/98 • Number of events 10 • 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.
Renal and urinary disorders Renal	8.2% 8/98 • Number of events 8 • 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.
Surgical and medical procedures Surgical Site Wound	1.0% 1/98 • Number of events 1 • 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.
Renal and urinary disorders Urogenital	5.1% 5/98 • Number of events 5 • 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.
Vascular disorders Vascular	4.1% 4/98 • Number of events 4 • 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.

Other adverse events

Measure	Single Arm Nellix EndoVascular Aneurysm Sealing System n=98 participants at risk Nellix EndoVascular Aneurysm Sealing System: The study is designed to evaluate the safety, effectiveness and performance of the Nellix System for endovascular aneurysm repair. Subjects will be followed procedurally to discharge, at 30 days (primary safety endpoint), six months, one year, two year (primary effectiveness endpoint) and annually thereafter to five years (total follow-up commitment).
Blood and lymphatic system disorders Bleeding/Anemia	0.00% 0/98 • 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.
Gastrointestinal disorders Bowel	1.0% 1/98 • Number of events 1 • 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.
Cardiac disorders Cardiac	3.1% 3/98 • Number of events 3 • 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.
Product Issues Nellix Device	1.0% 1/98 • Number of events 1 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignancies	2.0% 2/98 • Number of events 2 • 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.
General disorders Miscellaneous	12.2% 12/98 • Number of events 15 • 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.
Respiratory, thoracic and mediastinal disorders Chimney Device	0.00% 0/98 • 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.
Nervous system disorders Neurological	1.0% 1/98 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Pulmonary	0.00% 0/98 • 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.
Renal and urinary disorders Renal	3.1% 3/98 • Number of events 3 • 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.
Surgical and medical procedures Surgical Site Wound	1.0% 1/98 • Number of events 1 • 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.
Renal and urinary disorders Urogenital	5.1% 5/98 • Number of events 5 • 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.
Vascular disorders Vascular	2.0% 2/98 • Number of events 2 • 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.

Additional Information

Tammy Stiver, Manager, Clinical Affairs

Endologix LLC

Phone: +15136731452

Email: tstiver@endologix.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place