RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-12-03
Study Completion:2029-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04671771

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Bre Lester
CONTACT
4806986670
blester@wlgore.com
Harrison Kelner
CONTACT
2068225653
hkelner@wlgore.com

Principal Investigator

John Ross, MD
PRINCIPAL_INVESTIGATOR
MUSC Health Dialysis Access Institute

Study Locations (Sites)

Dialysis Access Institute
Orangeburg, South Carolina, 29118
United States
Baylor Heart and Vascular
Dallas, Texas, 75246
United States

Collaborators and Investigators

Sponsor: W.L.Gore & Associates

  • John Ross, MD, PRINCIPAL_INVESTIGATOR, MUSC Health Dialysis Access Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-03
Study Completion Date2029-07-01

Study Record Updates

Study Start Date2020-12-03
Study Completion Date2029-07-01

Terms related to this study

Additional Relevant MeSH Terms

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