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

Recruiting now · Not applicable

Conditions studied: End Stage Renal Disease (ESRD), Kidney Failure, Chronic Renal Disease, Hemodialysis

In brief

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.

Key facts

Study ID: NCT04671771
Run by: W.L.Gore & Associates
People needed: 133
Starts: 2020-12-03
Expected to finish: 2029-07-01
Last updated by the study team: 2025-12-22

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:
Patients with ESRD whose next most appropriate option for AV access is placement of an AV graft to start or maintain hemodialysis therapy;
Age 18 to 90 years old, inclusive;
Suitable anatomy for implantation of upper arm "straight" or looped graft, or forearm looped graft (graft not to cross the bend of the elbow);
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);
Able and willing to give informed consent;
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:
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;
Uncontrolled diabetes in the opinion of the investigator (i.e., multiple recent diabetes related hospitalizations);
For upper arm straight configuration, an antecubital fossa crease to axillary crease distance < 18 cm;
History or evidence of severe peripheral arterial disease in the extremity selected for implant (i.e., arterial inflow insufficient to support hemodialysis access);
Known or suspected central vein stenosis or obstruction on the side of planned graft implantation;
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;
Uncontrolled hypertension, per the opinion of the investigator (i.e., recent history of recurrent hospitalizations for hypertensive related illness);
Baseline hemoglobin <7 g/dL;
Baseline platelet count <50,000 or >500,000 cells/mm3;
Documented history of stroke within 6 months prior to enrollment;
Treatment with any investigational drug or device within 30 days prior to enrollment;
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);
History of cancer with active disease or treatment within the previous year, except for non-invasive basal or squamous cell carcinoma of the skin;

Where it is running

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

Full record on ClinicalTrials.gov

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