Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication (ChEVAS One)
Primary Purpose
1 Paravisceral Abdominal Aortic Aneurysm, 2 Juxtarenal Abdominal Aortic Aneurysm, 3 Pararenal Abdominal Aortic Aneurysm
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chimney Endovascular Aortic Sealing (ChEVAS) System
Sponsored by
About this trial
This is an interventional treatment trial for 1 Paravisceral Abdominal Aortic Aneurysm focused on measuring Paravisceral Abdominal Aortic Aneurysm, Juxtarenal Abdominal Aortic Aneurysm, Pararenal Abdominal Aortic Aneurysm, Complex Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm
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.
Sites / Locations
- Valley Vascular Consultants
- MedStar Health Research Institute
- Emory University
- St Vincent Medical Group
- University of Missouri
- Cooper University Hospital
- Icahn School of Medicine at Mount Sinai
- Providence Portland
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ChEVAS System
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04252573
Brief Title
Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication
Acronym
ChEVAS One
Official Title
Prospective, Multicenter, Non-randomized Study With Consecutive, Eligible Subject Enrollment at Each Site, for the Evaluation of the ChEVAS System for Endovascular Repair of Paravisceral, Juxtarenal, and Pararenal Abdominal Aortic Aneurysms.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 29, 2020 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endologix
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ChEVAS System
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Chimney Endovascular Aortic Sealing (ChEVAS) System
Other Intervention Name(s)
ChEVAS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of Technical Success, Safety and Effectiveness Indicators at One-Month Post-Index Procedure
Description
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.
Time Frame
1-Month
Title
Proportion of Safety and Effectiveness Indicators at One-Year Post-Index Procedure
Description
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.
Time Frame
1-Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Valley Vascular Consultants
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
MedStar Health Research Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
St Vincent Medical Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Providence Portland
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication
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