Clinical trial NCT04252573: Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Endologix
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Proportion of Technical Success, Safety and Effectiveness Indicators at One-Month Post-Index Procedure
timeFrame: 1-Month
measure: Proportion of Safety and Effectiveness Indicators at One-Year Post-Index Procedure
timeFrame: 1-Year
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Valley Vascular Consultants
state: Alabama
city: Washington
country: United States
facility: MedStar Health Research Institute
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Indianapolis
country: United States
facility: St Vincent Medical Group
state: Indiana
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Portland
country: United States
facility: Providence Portland
state: Oregon
Study officials:
References: