Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication

NCT ID: NCT04252573

Last Updated: 2024-12-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-29
• Study Completion Date: 2028-03-31

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.

Detailed Description

This is a prospective multicenter study with consecutive eligible subject enrollment at each site. Enrollment will include up to 150 subjects (120 ChEVAS subjects and up to 30 infrarenal roll-in subjects). The ChEVAS study will evaluate the safety and effectiveness outcomes following appropriate government and ethics committee/IRB requirements and guidelines.

All enrolled (ChEVAS and Infrarenal) subjects 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.

*As of October 27, 2021 ChEVAS ONE Study is voluntarily closed to screening and consenting. 13 subjects enrolled in the study will continue to be observed through 5-years.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Chimney Endovascular Aortic Sealing (ChEVAS) System

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

ChEVAS

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endologix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Valley Vascular Consultants

Huntsville, Alabama, United States

MedStar Health Research Institute

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

Emory University

Atlanta, Georgia, United States

St Vincent Medical Group

Indianapolis, Indiana, United States

University of Missouri

Columbia, Missouri, United States

Cooper University Hospital

Camden, New Jersey, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Providence Portland

Portland, Oregon, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CP-0015

Identifier Type: -

Identifier Source: org_study_id