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NCT04671771 · ClinicalTrials.gov registry record · NA
A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
A NA study of Kidney Failure and Hemodialysis, sponsored by W.L.Gore & Associates.
- Recruiting
- Registry status
- NA
- Development phase
- 133
- Enrollment target
- 20
- Study locations
NCT04671771 is a NA study of Kidney Failure and Hemodialysis that is actively recruiting participants, run by W.L.Gore & Associates. The registered enrollment target is 133 participants, below the 580-participant average among 18 other Kidney Failure trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT04671771, a NA study of Kidney Failure and Hemodialysis, is actively recruiting participants, sponsored by W.L.Gore & Associates.
- RECRUITING
- Registry status
- NA
- Development phase
- 133 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 133 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 580-participant average among 18 other Kidney Failure trials with a reported enrollment target (77% lower). The listed sponsor is W.L.Gore & Associates, which has 53 total studies on file at ClinicalTrials.gov.
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.
NCT04671771 reports 20 study locations spanning 12 distinct geographic areas - top geographies include North Carolina, New York, Florida.
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.
What interventions are being tested in trial NCT04671771?
The interventions under investigation include: InnAVasc Arteriovenous Graft (IG) surgical implant (DEVICE).
Who is sponsoring clinical trial NCT04671771?
This trial is sponsored by W.L.Gore & Associates, which has 53 total clinical trials registered on ClinicalTrials.gov.
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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Related
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