End Stage Renal Disease (ESRD)NCT04671771
A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
A study testing InnAVasc Arteriovenous Graft (IG) surgical implant in people with End Stage Renal Disease (ESRD) and Kidney Failure, run by W.L.Gore & Associates at 22 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- End Stage Renal Disease (ESRD), Kidney Failure, Chronic Renal Disease
- What is being tested?
- InnAVasc Arteriovenous Graft (IG) surgical implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 22 sitesUnited States
- Study dates
- 3 Dec 2020to 1 Sep 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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;
- 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;
- Documented or suspected hypercoagulable condition;
- Bleeding diathesis, other than that associated with ESRD;
- Documented history of heparin-induced thrombocytopenia (HIT);
- 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;
- Scheduled renal transplant within 6 months;
- Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and effectiveness of the IG;
- Patient is unable or unwilling to complete all required follow-up assessments and questionnaires.
Who cannot join
None listed.
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
United States22 sites, 21 recruiting
- Recruiting
Piedmont Augusta
Augusta, Georgia, 30901
Jennifer Hansen, 706-724-2463, Jennifer.Hansen@piedmont.org
Houman Tamaddon, MD
- Recruiting
University of Maryland
Baltimore, Maryland, 21201
Georges Jreij, 410-706-3037, GJreij@som.umaryland.edu
Langford Green, lwgreen@som.umaryland.edu
- Recruiting
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Lucinda Holden-Wingate, 617-525-8555, lholden-wingate@bwh.harvard.edu
Nicholas Swerdlow, MD
- Recruiting
Surgical Specialists of Charlotte
Charlotte, North Carolina, 28204
Decca Taylor, 704-945-3560, dtaylor@ssclt.com
Jason Burgess, MD
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27705
Ellen Burkett, 919-681-1878, ellen.jones@duke.edu
Tristen Chun, MD
- Recruiting
Prisma Health- Upstate
Greenville, South Carolina, 29615
Fabiana Barrero Castedo, Research Coordinator, 864-607-3405, Fabiana.Barrerocastedo@prismahealth.org
Sagar Gandhi, MD
- Recruiting
Houston Methodist Hopsital
Houston, Texas, 77030
Caroline Antunes, 346-238-4552, cantunes@houstonmethodist.org
Eric Peden, MD
- Recruiting
Sharp Center for Research
La Mesa, California, 91942
Cary Murphy, 619-740-4363, Cary.Murphy@sharp.com
Luis Cajas-Monson, MD
- Recruiting
University of Louisville
Louisville, Kentucky, 40202
Leslie Haysley, 502-852-2801, leslie.haysley@louisville.edu
Amit Dwivedi, MD
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
Romi Dave, 212-241-7108, Romi.Dave@mountsinai.org
Ajit Rao, MD
- Recruiting
Northwell Health
New York, New York, 10075
Nhan Tran, 212-434-3420, NNguyenTran@northwell.edu
Kenneth Nakazawa, MD
- Recruiting
Rutgers
Newark, New Jersey, 07103
Yanille Taveras, 973-972-6262, taveraya@njms.rutgers.edu
Saqib Zia, MD
- Recruiting
Methodist Physicians Clinic
Omaha, Nebraska, 68118
Dru McMartin, 402-354-0350, Dru.McMartin@nmhs.org
Rao Gutta, MD
- Recruiting
Medical University of South Carolina
Orangeburg, South Carolina, 29118
Virginia Anderson, RN, 803-395-3878, vdanderson@regmed.com
Amy Lawson, 803-395-2897, aclawson@regmed.com
- Recruiting
AKDHC Medical Research Services, LLC
Phoenix, Arizona, 85012
Cynthia Carrizoza, 602-200-8288, ccarrizoza@akdhc.com
Shouwen Wang, MD
- Active, not recruiting
NC Heart and Vascular Research, LLC
Raleigh, North Carolina, 27607
- Recruiting
WakeMed
Raleigh, North Carolina, 27610
Rhonda Norton, 919-350-5252, RNORTON@wakemed.org
Kirk Charles, MD
- Recruiting
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Stacy Pratt, 941-917-3616, Stacy-Pratt@smh.com
Inkyong Parrack, MD
- Recruiting
Guthrie Clinic
Sayre, Pennsylvania, 18840
Laura Warner, 570-887-6070, Laura.Warner@guthrie.org
Amber Hussain, MD
- Recruiting
University of Washington
Seattle, Washington, 98195
Alex Ruiz, 206-221-3883, aruiz06@uw.edu
Elina Quiroga, MD
- Recruiting
University of South Florida
Tampa, Florida, 33606
Avennette Pinto, 813-505-4787, apinto3@usf.edu
Aurelia Thibonnier, MD
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Agnieszka Siemienik, 718-920-4539, asiemien@montefiore.org
Sonia Talathi, MD
About this study
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.
Read the detailed description
The InnAVasc Arteriovenous Graft (IG) is intended for use in ESRD hemodialysis (HD) patients who require HD and whose next most appropriate access is an arteriovenous graft (AVG), also including those who may require an immediate cannulation AVG.
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.).
- Being tested
- InnAVasc Arteriovenous Graft (IG) surgical implant
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InnAVasc Arteriovenous Graft (IG) surgical implantDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental: InnAVasc AVG treatment | Experimental | 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). Receives: Device: InnAVasc Arteriovenous Graft (IG) surgical implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secondary patency of study device at 6 months
The primary effectiveness endpoint is defined as the proportion of subjects with secondary patency at 6 months.
Measured: 6 months
Incidence of adverse events of special interest related to InnAVasc AVG [Time Frame: through 6 months]
The primary safety endpoint is the incidence of device-related adverse events of special interest (AESIs) through 6 months, defined as:
- Infection of the study graft;
- Pseudoaneurysm formation at any point along the study graft requiring surgical or endovascular intervention (pseudoaneurysms that occur at sites of needle cannulation, but which are small enough to be observed without intervention, do not trigger this element of the AESI endpoint);
- Bleeding from the study graft requiring surgical or endovascular intervention or ≥2-unit blood transfusion;
- Hematoma from the study graft requiring surgical or endovascular intervention;
- Seroma of the study graft requiring surgical or endovascular intervention;
Measured: 6 months
Secondary outcomes (2)
Successful cannulation on or before Postoperative Day 7
Proportion of subjects achieving successful cannulation on or before Day 7, defined as the first 2-needle dialysis session through the study graft
Measured: 7 days
Sustained use
Proportion of subjects achieving sustained use of 3 months, 6, months, 12 months, 18 months and 24 months. Sustained use is a period of time in which the study graft is used for consecutive dialysis sessions without the requirement for alternative hemodialysis vascular access to be used as a route to receive renal replacement therapy. A sustained use period can be achieved at any time throughout the study period of 24 months.
Measured: 3, 6, 12, 18 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start3 Dec 2020
- Primary completion1 Mar 2030 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Disease (ESRD)Studies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective, multi-center, single-arm study
- Masking
- None (open label)
- Enrolment
- 133 participants (estimated)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Ross, MD, Principal investigator, MUSC Health Dialysis Access Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671771
- Sponsor's protocol ID
- CSP-2002
- Status last verified
- Oct 2026
- First submitted
- 5 Dec 2020
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31526086Gage 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.
PubMed 32370648