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TUVA BX and iCover Stent Grafts BEVAR Observational Study

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Summary

ClinicalTrials.gov registered an observational study collecting retrospective patient data on TUVA BX and iCover stent grafts used during branched endovascular aortic repair (BEVAR) to treat complex aortic aneurysms. The multi-center, single-arm study will review medical records from the original procedure through the 1-year follow-up visit for patients with thoracoabdominal aortic aneurysms or abdominal aortic aneurysms. No patient groups are assigned to specific interventions.

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What changed

ClinicalTrials.gov registered NCT07540507, an observational study evaluating the safety and performance of TUVA BX and iCover stent grafts during branched endovascular aortic repair (BEVAR) procedures. The retrospective, multi-center study will collect data from medical records starting at the original procedure and continuing through the 1-year follow-up visit, covering patients with thoracoabdominal aortic aneurysms or abdominal aortic aneurysms.

Medical device manufacturers and hospital systems conducting or sponsoring similar endovascular aortic repair studies should be aware that this registry documents real-world device use in clinical practice. The study has no comparison group and does not assign patients to specific interventions. Sponsors of BEVAR device studies may use this registry to assess the competitive landscape and clinical evidence development in this device category.

Archived snapshot

Apr 20, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

Data Collection of the TUVA BX and iCover Stent Grafts Implanted During Branched Endovascular Aortic Repair (BEVAR)

Observational NCT07540507 Kind: OBSERVATIONAL Apr 20, 2026

Abstract

The study aims to check whether the TUVA BX and iCover stent grafts are safe and work well when used during a specific type of minimally invasive surgery (BEVAR) to treat complex aortic aneurysms.

It is a retrospective study and it is conducted at multiple hospitals and does not include a comparison group.

Researchers will collect and review patient data from medical records, starting from the original procedure and continuing through the 1-year follow-up visit.

Conditions: TAAA, AAA - Abdominal Aortic Aneurysm

Interventions: Endovascular Aortic Repair

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Last updated

Classification

Agency
NIH
Published
April 20th, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Medical device makers Healthcare providers Clinical investigators
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical device post-market surveillance Clinical study participation Endovascular aortic repair
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Topics
Healthcare

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