Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication (NCT04252573) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication
United States13 participantsStarted 2020-06-29
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Proportion of Technical Success, Safety and Effectiveness Indicators at One-Month Post-Index Procedure
Timeframe: 1-Month
2
Proportion of Safety and Effectiveness Indicators at One-Year Post-Index Procedure