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Clinical Trials in the USA / NCT04252573
Active, not recruiting Not applicable

Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication

NCT04252573 · tracked via the Priya Life Science USA tracker
Sponsor
Endologix
Phase
Not applicable
Started
2020-06-29
Last updated
2026-04-21

Condition(s) studied

1 Paravisceral Abdominal Aortic Aneurysm2 Juxtarenal Abdominal Aortic Aneurysm3 Pararenal Abdominal Aortic Aneurysm4 Complex Abdominal Aortic Aneurysms

Investigational drug(s) / intervention(s)

Chimney Endovascular Aortic Sealing (ChEVAS) System

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

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

Trial sites (8)

FacilityCityRegionStatus
Valley Vascular Consultants Huntsville Alabama
MedStar Health Research Institute Washington D.C. District of Columbia
Emory University Atlanta Georgia
St Vincent Medical Group Indianapolis Indiana
University of Missouri Columbia Missouri
Cooper University Hospital Camden New Jersey
Icahn School of Medicine at Mount Sinai New York New York
Providence Portland Portland Oregon

More Endologix trials in the USA

The Long-Term EVAR Assessment and Follow-Up (LEAF) Study for the AFX2 System Active, not recruiting
JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization Recruiting
The Percutaneous Transmural Arterial Bypass -1 Study (Post Approval Registry) Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04252573 on ClinicalTrials.gov ↗ ← All trials in the USA