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A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
NCT04671771 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DEVICE InnAVasc Arteriovenous Graft (IG) surgical implant
Study Locations (20)
North Carolina
- Surgical Specialists of Charlotte — Charlotte
- Duke University Medical Center — Durham
- NC Heart and Vascular Research, LLC — Raleigh
- WakeMed — Raleigh
New York
- Mount Sinai Hospital — New York
- Northwell Health — New York
- Montefiore Medical Center — The Bronx
Florida
- Sarasota Memorial Hospital — Sarasota
- University of South Florida — Tampa
South Carolina
- Prisma Health- Upstate — Greenville
- Medical University of South Carolina — Orangeburg
Texas
- Baylor Heart and Vascular — Dallas
- Houston Methodist Hopsital — Houston
Arizona
- AKDHC Medical Research Services, LLC — Phoenix
Georgia
- Piedmont Augusta — Augusta
Kentucky
- University of Louisville — Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2020-12-03 |
| Est. Completion | 2029-07-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04671771
The ClinicalTrials.gov registry entry for NCT04671771 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 133 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is W.L.Gore & Associates, which has 117 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Kidney Failure appearing as the primary indexed condition, and to 1 intervention — of which InnAVasc Arteriovenous Graft (IG) surgical implant is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04671771 reports 20 study locations spanning 12 distinct geographic areas — top geographies include North Carolina, New York, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04671771 about?
NCT04671771 is a clinical study titled "A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease". 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...
What is the current status of trial NCT04671771?
This trial is currently recruiting. It is a NA study. The enrollment target is 133 participants. The study started on 2020-12-03. Estimated completion is 2029-07-01.
What conditions does trial NCT04671771 study?
This clinical trial studies the following conditions: Kidney Failure, Hemodialysis, End Stage Renal Disease (ESRD), Chronic Renal Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04671771?
The interventions under investigation include: InnAVasc Arteriovenous Graft (IG) surgical implant (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04671771?
This trial is sponsored by W.L.Gore & Associates, which has 117 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04671771 being conducted?
This trial has 20 study locations across Arizona, Florida, Georgia, Kentucky, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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