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Clinical Evaluation of a Vascular Venous Anastomotic Connector [InterGraft VIG-only Study]

NCT02532621 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2025-02-06

Study results available
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Summary

The InterGraft™ Venous Anastomotic Connector provides an endovascular, minimally invasive means for attachment of an arteriovenous graft to a vein in the upper extremity. The InterGraft™ Venous Anastomotic Connector facilitates creation of the arteriovenous graft connection to a vein in support of hemodialysis in subjects with End Stage Renal Disease. The InterGraft™ Venous Anastomotic Connector is used together with conventional suturing of the arterial anastomosis to facilitate creation of an arteriovenous graft in support of hemodialysis in subjects with End Stage Renal Disease.

Conditions

Interventions

DEVICE

Venous InterGraft Connector

The device is designed for transcatheter delivery within a vein and connection to an AVG that has been tunneled under the skin in a standard manner. The connection is made via a small skin incision.

PROCEDURE

sutured arterial anastomosis of an implanted vascular graft for hemodialysis

The arterial anastomosis of the implanted vascular graft for hemodialysis is formed using standard suturing technique.

PROCEDURE

hemodialysis

The implanted vascular graft is intended as a vascular access for performing hemodialysis treatments.

Sponsors & Collaborators

  • Phraxis, Inc.

    lead INDUSTRY

Principal Investigators

  • Cindy M Setum, Ph.D · Phraxis, Inc.

  • John R Ross, M.D. · Regional Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-21
Primary Completion
2022-01-19
Completion
2022-01-19
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 NCT02532621 on ClinicalTrials.gov