Evaluating the Safety and Effectiveness of the InnAVasc Graft for Dialysis Access in Patients With Kidney Failure
Public ClinicalTrials.gov record NCT03645681. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03645681
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 26 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 1, 2019
- Primary completion
- Sep 27, 2019
- Completion
- Jan 15, 2024
- Last update posted
- May 8, 2025
2019 – 2024
United States locations
- U.S. sites
- 7
- U.S. states
- 6
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| California Institute of Renal Research | San Diego | California | 92123 | — |
| Michigan Vascular Center | Flint | Michigan | 48507 | — |
| Greenwood Leflore Hospital | Greenwood | Mississippi | 38930 | — |
| Dialysis Access Institute at the Regional Medical Center | Orangeburg | South Carolina | 29118-1498 | — |
| Cardiothoracic and Vascular Surgeons | Austin | Texas | 78756 | — |
| Baylor Heart and Vascular Hospital | Dallas | Texas | 75226 | — |
| Inova Health Care Service | Falls Church | Virginia | 22042 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03645681, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 8, 2025 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03645681 live on ClinicalTrials.gov.