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Evaluating a new graft for hemodialysis access in patients with kidney failure

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

Not applicable Interventional W.L.Gore & Associates · NCT04671771

This study is testing a new type of graft for hemodialysis access to see if it is safe and effective for people with kidney failure.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment133 (estimated)
Ages18 Years to 90 Years
SexAll
SponsorW.L.Gore & Associates Industry-sponsored
Locations21 sites (Phoenix, Arizona and 20 other locations)
Trial IDNCT04671771 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and effectiveness of the InnAVasc Arteriovenous Graft (IG) for patients with end-stage renal disease (ESRD) who require hemodialysis access. Participants will undergo implantation of the graft using standard surgical techniques and will be monitored for device-related adverse events and the graft's patency over a period of two years. The study will include regular follow-up visits to evaluate the graft's performance and any complications that may arise. Eligible patients are those who have suitable anatomy for the graft and can adhere to antiplatelet therapy post-implantation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 90 with ESRD who require an arteriovenous graft for hemodialysis access.

Not a fit: Patients who do not require hemodialysis or have unsuitable anatomy for graft implantation may not benefit from this study.

Why it matters

Potential benefit: If successful, this graft could improve hemodialysis access for patients with ESRD, potentially leading to better treatment outcomes.

How similar studies have performed: Other studies have explored similar grafts for hemodialysis access, but the specific InnAVasc Arteriovenous Graft is being evaluated for its unique safety and effectiveness profile.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Phoenix, Arizona and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions End Stage Renal DiseaseKidney FailureChronic Renal DiseaseHemodialysis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.