Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication

NCT04252573 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: CP-0015
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 8

Brief Summary

Prospective, multi-center, non-randomized study with consecutive, eligible subject enrollment at each site, for the evaluation of the ChEVAS System for Endovascular Repair of Complex Abdominal Aortic Aneurysms.

Conditions

1 Paravisceral Abdominal Aortic Aneurysm; 2 Juxtarenal Abdominal Aortic Aneurysm; 3 Pararenal Abdominal Aortic Aneurysm; 4 Complex Abdominal Aortic Aneurysms

Keywords

Paravisceral Abdominal Aortic Aneurysm; Juxtarenal Abdominal Aortic Aneurysm; Pararenal Abdominal Aortic Aneurysm; Complex Abdominal Aortic Aneurysm; Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (2)

• Proportion of Technical Success, Safety and Effectiveness Indicators at One-Month Post-Index Procedure

  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.

  1-Month

• Proportion of Safety and Effectiveness Indicators at One-Year Post-Index Procedure

  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.

  1-Year

Study Arms (1)

ChEVAS System

EXPERIMENTAL

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.

Device: Chimney Endovascular Aortic Sealing (ChEVAS) System

Interventions

Chimney Endovascular Aortic Sealing (ChEVAS) System DEVICE

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.

Also known as: ChEVAS

ChEVAS System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults at least 18-years old
• Subject provided informed consent
• Subject agrees to all follow-up visits
• Abdominal aortic aneurysm (AAA) with maximum sac diameter ≥5.0 cm, or ≥ 4.5 cm which has increased by ≥ 0.5cm within the last 6-months, or which exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment. No AAA \<4cm will be included
• Absence of significant cranial angulation of the visceral vessels that would preclude vessel cannulation and stenting

You may not qualify if:

• Requirement of home oxygen
• Psychiatric or other condition that may interfere with the study
• Participating in another clinical drug and/or device study, which could confound the results of this study (patient must have completed the primary endpoint of any previous study at least 30-days prior to enrollment in this study)
• Known allergy or contraindication to any device material, contrast, or anticoagulants
• Serum creatinine level \>1.8mg/dL
• CVA or MI within three months of enrollment/treatment
• Prior stent in any target visceral vessel, the aorta or iliac artery that may interfere with delivery system introduction or stent placement
• Connective tissue diseases (e.g., Marfan Syndrome)
• Unsuitable vascular anatomy that may interfere with device introduction or deployment
• Pregnant, planning to become pregnant within 60 months, or breast feeding.

Sponsors & Collaborators

• Endologix: lead

Study Sites (8)

Valley Vascular Consultants

Huntsville, Alabama, 35801, United States

Location

MedStar Health Research Institute

Washington D.C., District of Columbia, 20010, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

St Vincent Medical Group

Indianapolis, Indiana, 46260, United States

Location

University of Missouri

Columbia, Missouri, 65212, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10019, United States

Location

Providence Portland

Portland, Oregon, 97213, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Results Point of Contact

• Title: Mohamed Moawad
• Organization: Endologix

mmoawad@endologix.com

949-595-7244

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 5, 2020
• Study Start: June 29, 2020
• Primary Completion: October 19, 2022
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 21, 2026
• Results First Posted: December 24, 2024

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)