Trial reportCardiovascular and interventional radiology2025
Six-Month Outcomes from the Prospective, Multi-Center, Non-Randomized Clinical Study of the COVERA
Trial report in Cardiovascular and interventional radiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04261686 (A Prospective, Multi-Center, Non-Randomized Clinical Study of the BARD® COVERA Arteriovenous), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Prospective, Multi-Center, Non-Randomized Clinical Study of the BARD® COVERA Arteriovenous (AV) Stent Graft in the Treatment of Stenosis in the Venous Outflow of AV Fistula Access Circuits (AVeNEW) Post Approval Study
Who cites it
1 citing paper in PubMed.
- Thrombin injection for the treatment of worsening brachiocephalic fistula pseudoaneurysm.Journal of vascular surgery cases and innovative techniques · 2025Article
Corrections and comments
- Erratum issued
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe AVeNEW Post-Approval Study (AVeNEW PAS) follows upon results from the AVeNEW IDE clinical trial and was designed to provide additional clinical evidence of safety and effectiveness using the Covera™ Vascular Covered Stent to treat arteriovenous fistula (AVF) stenoses in a real-world hemodialysis patient population. MATERIALS AND
methodsOne hundred AVF patients were prospectively enrolled at 11 clinical trial sites in the USA and treated with the covered stent after angioplasty of a clinically significant target stenosis. The primary safety outcome was freedom from any adverse event that suggests the involvement of the AV access circuit evaluated at 30 days. The primary efficacy outcome was Target Lesion Primary Patency (TLPP) at six months, determined by an independent core laboratory. Secondary outcome measures included technical success defined as successful deployment to the intended location and access circuit primary patency (ACPP).
resultsSafety was 94.9% with no device-related deaths nor in-patient hospitalization. Technical success was 100%. TLPP rates at 1, 3, and 6 months were 100, 89.7, and 82.2%. ACPP rates at 1, 3, and 6 months were 98, 76.3, and 60.0%. Target stenoses were 81% restenotic, and 75% located in the cephalic vein arch. There were 35% non-target stenoses treated with angioplasty during the index procedure.
conclusionThe 6-month results of the AVeNEW PAS confirm results from the AVeNEW IDE clinical trial and demonstrate safety and efficacy using the Covera
trial registrationNCT04261686. LEVEL OF EVIDENCE: 3 - prospective, multicenter.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.