Abdominal Aortic Aneurysm Without Rupture
Conditions
Brief summary
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.
Detailed description
This study will evaluate the safety and effectiveness of the Nellix System among a wide range of physicians and in consecutively enrolled subjects to assess safety and effectiveness outcomes. Following appropriate government and ethics committee/IRB approval the Nellix® EndoVascular Sealing System will be implanted into eligible patients who are adequately informed and have consented to join the study. Enrolled patients will undergo a high resolution, contrast-enhanced computed tomography angiography (CT) scan of the relevant aortic and aortoiliac vasculature within three months of the scheduled procedure and at specified follow-up intervals post-implantation. Follow-up visits will occur at 30 days, 6 months, and annually to 5 years to assess aneurysm morphology, the status of the implanted devices, and relevant laboratory test results.
Interventions
DEVICENellix® System
Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System
Sponsors
Endologix
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model 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. Sites have been chosen with a suitable research infrastructure and physician experience in endovascular aneurysm repair to ensure adequate enrollment. Subjects will be followed procedurally to discharge, at 30 days (primary safety endpoint), six months, one year (primary effectiveness endpoint) and annually thereafter to five years (total follow-up commitment).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A patient who meets all of the following criteria potentially may be included in the study: 1. Male or female at least 18 years old; 2. Informed consent form understood and signed 3. Patient agrees to all follow-up visits; 4. Abdominal aortic aneurysm with sac diameter ≥5.0cm, or ≥4.5cm which has increased by ≥0.5cm within the last 6 months, or or which exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment. No AAA \<4 cm will be included. 5. Anatomically eligible for the Nellix System (per Instructions For Use): 1. Adequate iliac/femoral access compatible with the required delivery systems (diameter ≥6 mm); 2. Aneurysm blood lumen diameter ≤60mm; 3. Proximal non-aneurysmal aortic neck: length ≥10mm; diameter 18 to 28mm; angle ≤60° to the aneurysm sac; 4. Most caudal renal artery to each hypogastric artery length ≥100mm; 5. Common iliac artery lumen diameter between 9 and 35mm; 6. Distal iliac artery seal zone with length of ≥10mm and diameter range of 9 to 25mm; 7. Ability to preserve at least one hypogastric artery. 8. Ratio of maximum aortic aneurysm diameter to maximum aortic blood lumen diameter \<1.40
Exclusion criteria
A patient who meets none of the following criteria potentially may be included in the study: 1. Life expectancy \<2 years as judged by the Investigator; 2. Psychiatric or other condition that may interfere with the study; 3. Participating in another clinical study; 4. Known allergy or contraindication to any device material; 5. Coagulopathy or uncontrolled bleeding disorder; 6. Ruptured, leaking or mycotic aneurysm; 7. Serum creatinine (S-Cr) level \>2.0 mg/dL; 8. CVA or MI within three months of enrollment/treatment; 9. Aneurysmal disease of the descending thoracic aorta; 10. Clinically significant mural thrombus within the proximal landing zone (minimum 10mm) of the infrarenal non-aneurysmal neck (\>5mm thickness over \>50% circumference); 11. Connective tissue diseases (e.g., Marfan Syndrome); 12. Unsuitable vascular anatomy that may interfere with device introduction or deployment; 13. Pregnant (female of childbearing potential only).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Major Adverse Events (MAE) | 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 |
| Effectiveness: Rate of Treatment Success | 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 Endoleak (Type I or Type III), Device obstruction or occlusion, Device migration, Abdominal aneurysm sac expansion, Device defect. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conversions, Death and Ruptures | 2 Years | Number of Deaths, Conversion and ruptures through the data cut of the July 7, 2023, |
| Device Integrity | 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). |
| Device Performance - Endoleak | 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). |
| DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Avg Size | 2 years | Average Sac Diameter size at Visit |
| DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Changes in Sac Size Since 01 Month | 2 Years | Number of subjects that had changes in the Sac Diameter size since the 1 month follow-up visit |
| Secondary Interventions | 2 Years | All Secondary interventions reported during the study |
| LABS-RENAL FUNCTION (EGFR) | 2 Years | The outcome demonstrates the protocol specified laboratory values (collected as eGFR) captured at each follow-up visit |
| LABS- RENAL FUNCTION (CREATININE) | 2 Years | Labs- Renal Function demonstrates the protocol specified laboratory values (Collected as creatinine) captured at each follow-up visit |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJeffrey Carpenter, MD
Cooper Hospital
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Nellix EndoVascular Aneurysm Sealing System 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). | 97 |
| Total | 97 |
Baseline characteristics
| Characteristic | Single Arm Nellix EndoVascular Aneurysm Sealing System |
|---|---|
| Age, Continuous | 73 years STANDARD_DEVIATION 9 |
| ASA Class (ASA Physical Status Classification System) ASA Class 1/2 | 32 Participants |
| ASA Class (ASA Physical Status Classification System) ASA Class 3/4/5 | 65 Participants |
| Height | 177 cm STANDARD_DEVIATION 10 |
| Race/Ethnicity, Customized Caucasian | 89 Participants |
| Race/Ethnicity, Customized Non Caucasian | 8 Participants |
| Region of Enrollment United States | 97 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 86 Participants |
| SVS Class (Society for Vascular Surgery Classification System) SVS/AAVS comorbidity score SVS Score: 0/1 | 93 Participants |
| SVS Class (Society for Vascular Surgery Classification System) SVS/AAVS comorbidity score SVS Score: 2/3/4 | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 98 |
| other Total, other adverse events | 22 / 98 |
| serious Total, serious adverse events | 49 / 98 |
Outcome results
Primary
Effectiveness: Rate of Treatment Success
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.
Time frame: 2 year
Population: Only 77 subjects completed study related procedures at 2 year time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nellix System | Effectiveness: Rate of Treatment Success | 92.2 percentage of treatment success |
Primary
Safety: Major Adverse Events (MAE)
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
Time frame: 30 days
Population: 98 patients enrolled under the study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nellix System | Safety: Major Adverse Events (MAE) | Death | 1 Number of Events |
| Nellix System | Safety: Major Adverse Events (MAE) | Myocardial Infarction | 2 Number of Events |
| Nellix System | Safety: Major Adverse Events (MAE) | Renal Failure | 2 Number of Events |
Secondary
Conversions, Death and Ruptures
Number of Deaths, Conversion and ruptures through the data cut of the July 7, 2023,
Time frame: 2 Years
Population: 93 subjects that completed their 2 year visit as of the data cut off of 07Jul2023
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nellix System | Conversions, Death and Ruptures | Conversion | 0 Number of Events |
| Nellix System | Conversions, Death and Ruptures | Deaths | 7 Number of Events |
| Nellix System | Conversions, Death and Ruptures | Ruptures | 0 Number of Events |
Secondary
Device Integrity
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nellix System | Device Integrity | Stenosis | 5 Number of Events |
| Nellix System | Device Integrity | Stent Occlusion | 4 Number of Events |
| Nellix System | Device Integrity | Migration>5mm | 1 Number of Events |
| Nellix System | Device Integrity | Migration >10mm | 0 Number of Events |
| Nellix System | Device Integrity | Stent Kinking | 0 Number of Events |
| Nellix System | Device Integrity | Stent Fracture | 0 Number of Events |
Secondary
DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Avg Size
Average Sac Diameter size at Visit
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nellix System | DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Avg Size | 55.4 mm | Standard Deviation 5.9 |
Secondary
DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Changes in Sac Size Since 01 Month
Number of subjects that had changes in the Sac Diameter size since the 1 month follow-up visit
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nellix System | DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Changes in Sac Size Since 01 Month | Decreased >5mm | 3 Number of subjects |
| Nellix System | DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Changes in Sac Size Since 01 Month | Stable +- 5mm | 69 Number of subjects |
| Nellix System | DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Changes in Sac Size Since 01 Month | Increased >5mm | 4 Number of subjects |
| Nellix System | DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Changes in Sac Size Since 01 Month | No Growth | 72 Number of subjects |
Secondary
Device Performance - Endoleak
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).
Time frame: 2 Years
Population: 75 subjects analyzed for Endoleaks at 2 years as of the data cut-off date of 07Jul2023
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nellix System | Device Performance - Endoleak | Endoleak Type II | 6 Participants |
| Nellix System | Device Performance - Endoleak | Endoleak Type III | 0 Participants |
| Nellix System | Device Performance - Endoleak | Endoleak Type IV | 0 Participants |
| Nellix System | Device Performance - Endoleak | Endoleak Unknown | 1 Participants |
| Nellix System | Device Performance - Endoleak | Endoleak Type IA | 5 Participants |
| Nellix System | Device Performance - Endoleak | Endoleak Type IB | 1 Participants |
Secondary
LABS- RENAL FUNCTION (CREATININE)
Labs- Renal Function demonstrates the protocol specified laboratory values (Collected as creatinine) captured at each follow-up visit
Time frame: 2 Years
Population: 80 subjects analyzed for renal function (Creatinine) at 2 years as of the data cut-off date of 07Jul2023
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nellix System | LABS- RENAL FUNCTION (CREATININE) | 1.19 mg/dL | Standard Deviation 0.42 |
Secondary
LABS-RENAL FUNCTION (EGFR)
The outcome demonstrates the protocol specified laboratory values (collected as eGFR) captured at each follow-up visit
Time frame: 2 Years
Population: 80 subjects analyzed for renal function (eGFR) at 2 years as of the data cut-off date of 07Jul2023
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nellix System | LABS-RENAL FUNCTION (EGFR) | 66 mL/min/1.73 m^2 | Standard Deviation 24 |
Secondary
Secondary Interventions
All Secondary interventions reported during the study
Time frame: 2 Years
Population: 93 subjects analyzed for the number of secondary interventions
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nellix System | Secondary Interventions | Conversion to open repair due to aneurysm expansion | 0 Number of Events |
| Nellix System | Secondary Interventions | Iliac Extension due to aneurysm expansion | 1 Number of Events |
| Nellix System | Secondary Interventions | Iliac Stenting due to renal failure | 1 Number of Events |
| Nellix System | Secondary Interventions | Renal stent due to renal failure | 1 Number of Events |
| Nellix System | Secondary Interventions | Iliac Extension due to Vessel Dissection (Non aortic) | 1 Number of Events |
| Nellix System | Secondary Interventions | Thrombolysis due to Vessel Dissection (Non aortic) | 1 Number of Events |
| Nellix System | Secondary Interventions | Conversion to Open Repair due to endoleak IA | 0 Number of Events |
| Nellix System | Secondary Interventions | Coil Embolization due to Endoleak II | 1 Number of Events |
| Nellix System | Secondary Interventions | Thrombolysis due to Stent Thrombosis | 2 Number of Events |
| Nellix System | Secondary Interventions | Stent relining due to Stent Thrombosis | 1 Number of Events |
| Nellix System | Secondary Interventions | Fem-Fem Bypass due to Stent Thrombosis | 1 Number of Events |
| Nellix System | Secondary Interventions | Conversion to Open Repair due to stent migration | 0 Number of Events |
| Nellix System | Secondary Interventions | Renal stent due to Renal Artery Occlusion | 1 Number of Events |