Trial Outcomes & Findings for Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication (NCT NCT04252573)

Results Overview

The outcome at one-month post index procedure will be measured by the proportion of subjects that experience technical success and the absence of severe bowel ischemia, permanent paraplegia/paraparesis, renal failure, disabling stroke, abdominal aortic aneurysm rupture, and aneurysm-related mortality within 30-days of the index procedure.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

NA

Target enrollment

13 participants

Primary outcome timeframe

1-Month

Results posted on

2024-12-24

Participant Flow

Participant milestones

Participant milestones
Measure	ChEVAS System The ChEVAS procedure involves the use of the Nellix System in conjunction with parallel branch chimney stents for the treatment of juxtarenal, pararenal, or paravisceral abdominal aortic aneurysms. Chimney Endovascular Aortic Sealing (ChEVAS) System: The ChEVAS procedure involves the use of the Nellix System in conjunction with parallel branch chimney stents for the treatment of juxtarenal, pararenal, or paravisceral abdominal aortic aneurysms.
Overall Study STARTED	13
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ChEVAS System n=13 Participants The ChEVAS procedure involves the use of the Nellix System in conjunction with parallel branch chimney stents for the treatment of juxtarenal, pararenal, or paravisceral abdominal aortic aneurysms. Chimney Endovascular Aortic Sealing (ChEVAS) System: The ChEVAS procedure involves the use of the Nellix System in conjunction with parallel branch chimney stents for the treatment of juxtarenal, pararenal, or paravisceral abdominal aortic aneurysms.
Age, Continuous	74 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	8 Participants n=5 Participants
Race/Ethnicity, Customized Non-Caucasian	5 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 1-Month

The outcome at one-month post index procedure will be measured by the proportion of subjects that experience technical success and the absence of severe bowel ischemia, permanent paraplegia/paraparesis, renal failure, disabling stroke, abdominal aortic aneurysm rupture, and aneurysm-related mortality within 30-days of the index procedure.

Outcome measures

Outcome measures
Measure	ChEVAS System n=13 Participants The ChEVAS procedure involves the use of the Nellix System in conjunction with parallel branch chimney stents for the treatment of juxtarenal, pararenal, or paravisceral abdominal aortic aneurysms. Chimney Endovascular Aortic Sealing (ChEVAS) System: The ChEVAS procedure involves the use of the Nellix System in conjunction with parallel branch chimney stents for the treatment of juxtarenal, pararenal, or paravisceral abdominal aortic aneurysms.
Proportion of Technical Success, Safety and Effectiveness Indicators at One-Month Post-Index Procedure	13 Participants

PRIMARY outcome

Timeframe: 1-Year

The outcome at one-year post index procedure will be measured by the proportion of subjects that experience freedom from abdominal aortic aneurysm rupture and aneurysm-related mortality up until 1-year (day 365), freedom from imaging-related findings in the 1-year window (Type 1 or 3 endoleak, migration \> 10mm, AAA sac expansion \> 5mm, and occlusion within the ChEVAS System not seen at the index procedure), and open conversion through day 365.

Outcome measures

Outcome measures
Measure	ChEVAS System n=13 Participants The ChEVAS procedure involves the use of the Nellix System in conjunction with parallel branch chimney stents for the treatment of juxtarenal, pararenal, or paravisceral abdominal aortic aneurysms. Chimney Endovascular Aortic Sealing (ChEVAS) System: The ChEVAS procedure involves the use of the Nellix System in conjunction with parallel branch chimney stents for the treatment of juxtarenal, pararenal, or paravisceral abdominal aortic aneurysms.
Proportion of Safety and Effectiveness Indicators at One-Year Post-Index Procedure	10 Participants

Adverse Events

ChEVAS System

Serious events: 4 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ChEVAS System n=13 participants at risk The ChEVAS procedure involves the use of the Nellix System in conjunction with parallel branch chimney stents for the treatment of juxtarenal, pararenal, or paravisceral abdominal aortic aneurysms. Chimney Endovascular Aortic Sealing (ChEVAS) System: The ChEVAS procedure involves the use of the Nellix System in conjunction with parallel branch chimney stents for the treatment of juxtarenal, pararenal, or paravisceral abdominal aortic aneurysms.
Cardiac disorders Hypertension	23.1% 3/13 • Number of events 3 • 1 Year
Surgical and medical procedures Compartment Syndrome	7.7% 1/13 • Number of events 1 • 1 Year
Nervous system disorders Neurological	15.4% 2/13 • Number of events 2 • 1 Year
Vascular disorders Endoleak Type 1A	7.7% 1/13 • Number of events 1 • 1 Year
Gastrointestinal disorders Miscellaneous- Inguinal hernia	7.7% 1/13 • Number of events 1 • 1 Year

Other adverse events

Other adverse events
Measure	ChEVAS System n=13 participants at risk The ChEVAS procedure involves the use of the Nellix System in conjunction with parallel branch chimney stents for the treatment of juxtarenal, pararenal, or paravisceral abdominal aortic aneurysms. Chimney Endovascular Aortic Sealing (ChEVAS) System: The ChEVAS procedure involves the use of the Nellix System in conjunction with parallel branch chimney stents for the treatment of juxtarenal, pararenal, or paravisceral abdominal aortic aneurysms.
Surgical and medical procedures Bleeding/Anemia	7.7% 1/13 • Number of events 1 • 1 Year
Cardiac disorders Cardiac	7.7% 1/13 • Number of events 1 • 1 Year
General disorders Miscellaneous	7.7% 1/13 • Number of events 1 • 1 Year
Product Issues Nellix Device	15.4% 2/13 • Number of events 2 • 1 Year
Surgical and medical procedures Surgical Site Wound	7.7% 1/13 • Number of events 1 • 1 Year
Vascular disorders Vascular	38.5% 5/13 • Number of events 5 • 1 Year

Additional Information

Mohamed Moawad

Endologix

Phone: 949-595-7244

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place