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NCT03645681 · ClinicalTrials.gov registry record · NA
Evaluating the Safety and Effectiveness of the InnAVasc Graft for Dialysis Access in Patients With Kidney Failure
A NA study, sponsored by W.L.Gore & Associates.
- Terminated
- Registry status
- NA
- Development phase
- 26
- Enrollment target
NCT03645681: Clinical Trial NA study, sponsored by W.L.Gore & Associates.
NCT03645681 is a NA study that was terminated before completion, run by W.L.Gore & Associates. The registered enrollment target is 26 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03645681, a NA study, was terminated before completion, sponsored by W.L.Gore & Associates.
- TERMINATED
- Registry status
- NA
- Development phase
- 26 participants
- Enrollment target
Study Summary
The CSP-1001 study will evaluate the safety and effectiveness of the InnAVasc arteriovenous graft (AVG) when implanted in and used for hemodialysis in participants suffering from end stage renal failure (ESRD). The InnAVasc AVG is implanted and used similar to other standard of care dialysis grafts currently on the market. However, the InnAVasc AVG has been uniquely designed to potentially allow for immediate needle access (same day as implant surgery as opposed to 2-4 weeks of waiting), to potentially reduce excessive bleeding from the graft after dialysis, and it may provide protection from improper or missed needle cannulation attempts.
Primary Outcome
Secondary patency is defined as the number of patients free from abandonment, including surgical or endovascular interventions designed to reestablish AVG patency at the 6 month timepoint.
Interventions
- DEVICE InnAVasc arteriovenous graft surgical implant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2019-01-02 |
| Est. Completion | 2024-01-16 |
| Phase | NA |
Why NCT03645681 stopped before completion
NCT03645681 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which InnAVasc arteriovenous graft surgical implant is the first listed.
NCT03645681 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03645681 about?
NCT03645681 is a clinical study titled "Evaluating the Safety and Effectiveness of the InnAVasc Graft for Dialysis Access in Patients With Kidney Failure". The CSP-1001 study will evaluate the safety and effectiveness of the InnAVasc arteriovenous graft (AVG) when implanted in and used for hemodialysis in participants suffering from end stage renal failure (ESRD). The InnAVasc AVG is implanted and used similar to other standard of care dialysis grafts ...
What is the current status of trial NCT03645681?
This trial is currently terminated. It is a NA study. The enrollment target is 26 participants. The study started on 2019-01-02. Estimated completion is 2024-01-16.
What interventions are being tested in trial NCT03645681?
The interventions under investigation include: InnAVasc arteriovenous graft surgical implant (DEVICE).
Who is sponsoring clinical trial NCT03645681?
This trial is sponsored by W.L.Gore & Associates, which has 53 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03645681's enrollment target sits among peer trials
26 1710th of 2000 higher than 289 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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