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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: Recruiting NA study of Kidney Failure and Hemodialysis, sponsored by W.L.Gore & Associates.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary effectiveness endpoint is defined as the proportion of subjects with secondary patency at 6 months.
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 |
What NCT04671771 shows while recruiting
NCT04671771 is an interventional study that assigns participants to a tested intervention. The registered 133 participants enrollment target is mid-sized for trials with a published cap, below the 580-participant average among 18 other Kidney Failure trials with a reported enrollment target (77% lower).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04671771's enrollment target sits among peer trials
133 9th of 18 higher than 10 of 18 other Kidney Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Failure 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.
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