Last reviewed · How we verify
NCT05846581: AVG22-09
Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access
trial testing GORE® ACUSEAL Vascular Graft in Chronic Kidney Diseases in 72 participants. Currently enrolling.
27 October 2027
Quick facts
| Lead sponsor | W.L.Gore & Associates |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 72 |
| Start date | 12 January 2024 |
| Primary completion | 27 October 2027 |
| Estimated completion | 27 October 2027 |
| Sites | 5 locations across Italy, United Kingdom, Germany |
Drugs / interventions tested
- GORE® ACUSEAL Vascular Graft
Conditions studied
- Chronic Kidney Diseases — all drugs for Chronic Kidney Diseases →
- End Stage Renal Disease on Dialysis — all drugs for End Stage Renal Disease on Dialysis →
Sponsor
W.L.Gore & Associates — full company profile →
Who can join
18 and older, any sex, with Chronic Kidney Diseases or End Stage Renal Disease on Dialysis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this observational study is to evaluate safety and performance of GORE® ACUSEAL Vascular Graft for the treatment of CKD in patients with ESRD in hemodialysis. The main questions it aims to answer are: * Safety: Freedom from device-related infection adverse events at 24 months from device implant * Performance: Secondary patency at 24 months from device implant. Participants, after informed consent is obtained, will be implanted with GORE® ACUSEAL Vascular Graft and followed for 24 months in standard of care, to evaluate safety and performance of the device.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05846581
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other W.L.Gore & Associates trials
Trials by the same sponsor.
- NCT07147569 — TAMBE Japan Post-Marketing Surveillance · recruiting
- NCT06827990 — GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections · NA · recruiting
- NCT06872905 — Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular · recruiting
- NCT06578741 — GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study · NA · enrolling by invitation
- NCT06174376 — Clinical Outcomes of the Gore Synthetic Cornea Device · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05846581 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by W.L.Gore & Associates
- Last refreshed: 9 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05846581.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing