RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: W.L.Gore & Associates • ClinicalTrials.gov ID: NCT04671771

Registry updated: 2026-10-08

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

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.

Interventions

InnAVasc Arteriovenous Graft (IG) surgical implant (Device)
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

Eligibility criteria

Inclusion Criteria: Pre-Operative Inclusion Criteria: Patients must meet the following criteria at screening in order to be scheduled for a procedure and potentially enrolled in the study: 1. Patients with ESRD whose next most appropriate option for AV access is placement of an AV graft to start or maintain hemodialysis therapy; 2. Age 18 to 90 years old, inclusive; 3. Suitable anatomy for implantation of upper arm "straight" or looped graft, or forearm looped graft (graft not to cross the bend of the elbow); 4. Ability to continue or commence antiplatelet therapy post graft implant (anticoagulation medication is acceptable if the subject is required to take an anticoagulant for a baseline medical condition); 5. Able and willing to give informed consent; 6. Anticipated life expectancy of at least 1 year. Intra-Operative Inclusion Criteria: Both vessels have been exposed and are deemed appropriate for implantation (i.e., based on the surgeon's opinion, artery is of adequate size, has adequate pulse to support AV access flow, is without significant calcification, and is safely clampable; and the vein is of adequate size, free of localized sclerosis, and is free of immediate outflow obstruction). Pre-Operative Exclusion Criteria: Patients will be excluded from the study at screening if they exhibit any of the following exclusion criteria: 1. History or evidence of severe cardiac disease (i.e., debilitating heart failure, or high risk of MI) in the opinion of the investigator which may preclude participation in and completion of the study; 2. Uncontrolled diabetes in the opinion of the investigator (i.e., multiple recent diabetes related hospitalizations); 3. For upper arm straight configuration, an antecubital fossa crease to axillary crease distance \< 18 cm; 4. History or evidence of severe peripheral arterial disease in the extremity selected for implant (i.e., arterial inflow insufficient to support hemodialysis access); 5. Known or suspected central vein stenosis or obstruction on the side of planned graft implantation; 6. Baseline hypotension or history of frequent hypotensive episodes during dialysis that, in the opinion of the investigator, puts the patient at increased risk of graft thrombosis; 7. Uncontrolled hypertension, per the opinion of the investigator (i.e., recent history of recurrent hospitalizations for hypertensive related illness); 8. Baseline hemoglobin \<7 g/dL; 9. Baseline platelet count \<50,000 or \>500,000 cells/mm3; 10. Documented history of stroke within 6 months prior to enrollment; 11. Treatment with any investigational drug or device within 30 days prior to enrollment; 12. Female patients who are pregnant, intending to become pregnant, nursing or intending to breastfeed during the study (pregnancy test may only be omitted, if patient is post-menopausal or has a documented history of hysterectomy or permanent sterilization); 13. History of cancer with active disease or treatment within the previous year, except for non-invasive basal or squamous cell carcinoma of the skin; 14. Immunodeficiency including documented history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) or patients receiving immunosuppressive therapy for treatment of an acute inflammatory event or autoimmune flare. Chronic immunosuppressive therapy is acceptable; 15. Documented or suspected hypercoagulable condition; 16. Bleeding diathesis, other than that associated with ESRD; 17. Documented history of heparin-induced thrombocytopenia (HIT); 18. Active local or systemic infection as documented from the medical history or bloodwork/blood culture data. If the infection resolves, the subject must be at least one-week post resolution of that infection before implantation; 19. Scheduled renal transplant within 6 months; 20. Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and effectiveness of the IG; 21. Patient is unable or unwilling to complete all required follow-up assessments and questionnaires.

Conditions

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

Locations

AKDHC Medical Research Services, LLC — Phoenix, Arizona, United States
Sharp Center for Research — La Mesa, California, United States
Sarasota Memorial Hospital — Sarasota, Florida, United States
University of South Florida — Tampa, Florida, United States
Piedmont Augusta — Augusta, Georgia, United States
University of Louisville — Louisville, Kentucky, United States
University of Maryland — Baltimore, Maryland, United States
Brigham & Women's Hospital — Boston, Massachusetts, United States
Methodist Physicians Clinic — Omaha, Nebraska, United States
Rutgers — Newark, New Jersey, United States
Mount Sinai Hospital — New York, New York, United States
Northwell Health — New York, New York, United States
Montefiore Medical Center — The Bronx, New York, United States
Surgical Specialists of Charlotte — Charlotte, North Carolina, United States
Duke University Medical Center — Durham, North Carolina, United States
NC Heart and Vascular Research, LLC — Raleigh, North Carolina, United States
WakeMed — Raleigh, North Carolina, United States
Guthrie Clinic — Sayre, Pennsylvania, United States
Prisma Health- Upstate — Greenville, South Carolina, United States
Medical University of South Carolina — Orangeburg, South Carolina, United States
Houston Methodist Hopsital — Houston, Texas, United States
University of Washington — Seattle, Washington, United States

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment