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

NCT04671771 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2025-12-22

No results posted yet for this 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

  • End Stage Renal Disease (ESRD)
  • Kidney Failure
  • Chronic Renal Disease
  • Hemodialysis

Interventions

DEVICE

InnAVasc Arteriovenous Graft (IG) surgical implant

The InnAVasc Arteriovenous Graft (IG) is a hemodialysis vascular access graft, intended for implantation in the lower or upper arm using standard vascular techniques, in patients requiring hemodialysis

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Principal Investigators

  • John Ross, MD · MUSC Health Dialysis Access Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-03
Primary Completion
2027-12-01
Completion
2029-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04671771 on ClinicalTrials.gov