A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease

ClinicalTrials.gov ID: NCT04671771

Public ClinicalTrials.gov record NCT04671771. 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.

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ClinicalTrials.gov public records Last synced Oct 20, 2026, 3:12 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT04671771
Recruitment status: Recruiting
Study type: Interventional
Phase: Not applicable
Lead sponsor: W.L.Gore & Associates; Industry
Enrollment: 133 participants

Conditions and interventions

Conditions

Interventions

InnAVasc Arteriovenous Graft (IG) surgical implant Device

Device

Eligibility (public fields only)

Age range: 18 Years to 90 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: Dec 3, 2020 (Actual)
Primary completion: Mar 1, 2030 (Estimated)
Completion: Sep 1, 2031 (Estimated)
Last update posted: Oct 8, 2026

2020 – 2031

United States locations

U.S. sites: 22
U.S. states: 15
U.S. cities: 20

Facility	City	State	ZIP	Site status
AKDHC Medical Research Services, LLC	Phoenix	Arizona	85012	Recruiting
Sharp Center for Research	La Mesa	California	91942	Recruiting
Sarasota Memorial Hospital	Sarasota	Florida	34239	Recruiting
University of South Florida	Tampa	Florida	33606	Recruiting
Piedmont Augusta	Augusta	Georgia	30901	Recruiting
University of Louisville	Louisville	Kentucky	40202	Recruiting
University of Maryland	Baltimore	Maryland	21201	Recruiting
Brigham & Women's Hospital	Boston	Massachusetts	02115	Recruiting
Methodist Physicians Clinic	Omaha	Nebraska	68118	Recruiting
Rutgers	Newark	New Jersey	07103	Recruiting
Mount Sinai Hospital	New York	New York	10029	Recruiting
Northwell Health	New York	New York	10075	Recruiting
Montefiore Medical Center	The Bronx	New York	10467	Recruiting
Surgical Specialists of Charlotte	Charlotte	North Carolina	28204	Recruiting
Duke University Medical Center	Durham	North Carolina	27705	Recruiting
NC Heart and Vascular Research, LLC	Raleigh	North Carolina	27607	Active, not recruiting
WakeMed	Raleigh	North Carolina	27610	Recruiting
Guthrie Clinic	Sayre	Pennsylvania	18840	Recruiting
Prisma Health- Upstate	Greenville	South Carolina	29615	Recruiting
Medical University of South Carolina	Orangeburg	South Carolina	29118	Recruiting
Houston Methodist Hopsital	Houston	Texas	77030	Recruiting
University of Washington	Seattle	Washington	98195	Recruiting

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 NCT04671771, 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 Oct 8, 2026 · Synced Oct 20, 2026

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The complete public registry record, listed eligibility criteria, and available contact information for NCT04671771 live on ClinicalTrials.gov.

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