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NCT04671771
A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
NA trial testing InnAVasc Arteriovenous Graft (IG) surgical implant in End Stage Renal Disease (ESRD) in 133 participants. Currently enrolling.
1 December 2027
Quick facts
| Lead sponsor | W.L.Gore & Associates |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 133 |
| Start date | 3 December 2020 |
| Primary completion | 1 December 2027 |
| Estimated completion | 1 July 2029 |
| Sites | 21 locations across United States |
Drugs / interventions tested
- InnAVasc Arteriovenous Graft (IG) surgical implant
Conditions studied
- End Stage Renal Disease (ESRD) — all drugs for End Stage Renal Disease (ESRD) →
- Kidney Failure — all drugs for Kidney Failure →
- Chronic Renal Disease — all drugs for Chronic Renal Disease →
- Hemodialysis — all drugs for Hemodialysis →
Sponsor
W.L.Gore & Associates — full company profile →
Who can join
Adults 18 to 90, any sex, with End Stage Renal Disease (ESRD) or Kidney Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of the CSP-2002 clinical trial is to evaluate the safety and effectiveness of the InnAVasc Arteriovenous Graft (IG) for hemodialysis (HD) access in patients with end-stage renal disease (ESRD). The primary study endpoints are: Primary Effectiveness Endpoint: The proportion of subjects with secondary patency at 6 months. Primary Safety Endpoint: The incidence of device-related adverse events of special interest (AESIs) through 6 months. Participants will be asked to sign an informed consent form. Once enrolled, they will be assessed to receive the study graft implant and asked to participate in periodic follow-up visits and assessments through 2 years following implant.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04671771
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Other W.L.Gore & Associates trials
Trials by the same sponsor.
- NCT07147569 — TAMBE Japan Post-Marketing Surveillance · recruiting
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- NCT06872905 — Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular · recruiting
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- 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 NCT04671771 (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: 22 December 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/NCT04671771.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing