A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
NCT ID: NCT04671771
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
133 participants
INTERVENTIONAL
2020-12-03
2029-07-01
Brief Summary
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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.
Detailed Description
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Patients with ESRD who require HD and are suitable for an AVG for HD access will be eligible for inclusion in the study. Subjects will be implanted with an InnAVasc Arteriovenous Graft (IG) in the forearm or upper arm using standard vascular surgical techniques. The graft will be placed in a "straight" (soft "C") configuration in the upper arm, or looped configuration in the forearm (forearm loop) or upper arm (axillary loop). Placing the graft across the elbow will be prohibited. Subjects must be able to be on antiplatelet therapy per the discretion of their physician (e.g., aspirin, clopidogrel, etc.).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental: InnAVasc AVG treatment
Patients will be surgically implanted with an InnAVasc Arteriovenous Graft (IG) in the forearm or upper arm using standard vascular surgical techniques. The graft will be placed in a "straight" (soft "C") configuration in the upper arm, or looped configuration in the forearm (forearm loop) or upper arm (axillary loop).
InnAVasc Arteriovenous Graft (IG) surgical implant
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
Interventions
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InnAVasc Arteriovenous Graft (IG) surgical implant
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
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Inclusion Criteria
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.
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).
Exclusion Criteria
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.
18 Years
90 Years
ALL
No
Sponsors
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W.L.Gore & Associates
INDUSTRY
Responsible Party
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Principal Investigators
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John Ross, MD
Role: PRINCIPAL_INVESTIGATOR
MUSC Health Dialysis Access Institute
Locations
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AKDHC Medical Research Services, LLC
Phoenix, Arizona, 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
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
Baylor Heart and Vascular
Dallas, Texas, United States
Houston Methodist Hopsital
Houston, Texas, United States
University of Washington
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Cynthia Carrizoza
Role: primary
Stacy Pratt
Role: primary
Avennette Pinto
Role: primary
Jennifer Hansen
Role: primary
Leslie Haysley
Role: primary
Georges Jreij
Role: primary
Navya Kotturu
Role: primary
Yanille Taveras
Role: primary
Catherine Marin
Role: primary
Nhan Tran
Role: primary
Agnieszka Siemienik
Role: primary
Decca Taylor
Role: primary
Ellen Burkett
Role: primary
Rhonda Norton
Role: primary
Laura Warner
Role: primary
Maggie Salle, RN- Research Coordinator
Role: primary
Virginia Anderson, RN
Role: primary
Amy Lawson
Role: backup
Katalin Martits-Chalangari
Role: primary
Mariana Hurutado
Role: backup
Caroline Antunes
Role: primary
Alex Ruiz
Role: primary
References
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Gage SM, Lawson M, Nichols C, Sycks D, Manson RJ, Knight JA. An immediate access dialysis graft designed to prevent needle-related complications: Results from the initial pre-clinical studies. J Vasc Access. 2020 May;21(3):328-335. doi: 10.1177/1129729819874987. Epub 2019 Sep 16.
Gage SM, Illig KA, Ross JR. Use of a novel immediate access dialysis graft designed to prevent needle-related complications: A first-in-man case report. J Vasc Access. 2021 May;22(3):475-479. doi: 10.1177/1129729820917265. Epub 2020 May 5.
Other Identifiers
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CSP-2002
Identifier Type: -
Identifier Source: org_study_id