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

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.

Study Overview

• Status: Recruiting
• Conditions: Hemodialysis; Kidney Failure; End Stage Renal Disease (ESRD); Chronic Renal Disease
• Intervention / Treatment: Device: InnAVasc Arteriovenous Graft (IG) surgical implant

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.).

• Study Type: Interventional
• Enrollment (Estimated): 133
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bre Lester; Phone Number: 4806986670; Email: blester@wlgore.com
• Study Contact Backup: Name: Manali Joglekar; Phone Number: 9288644063; Email: mjogleka@wlgore.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Recruiting
      • AKDHC Medical Research Services, LLC
      • Contact: Cynthia Carrizoza; Phone Number: 602-200-8288; Email: ccarrizoza@akdhc.com
      • Principal Investigator: Shouwen Wang, MD
  • Florida
    • Sarasota, Florida, United States, 34239
      • Recruiting
      • Sarasota Memorial Hospital
      • Contact: Stacy Pratt; Phone Number: 941-917-3616; Email: stacy-pratt@smh.com
      • Principal Investigator: Inkyong Parrack, MD
    • Tampa, Florida, United States, 33606
      • Recruiting
      • University of South Florida
      • Contact: Avennette Pinto; Phone Number: 813-505-4787; Email: apinto3@usf.edu
      • Principal Investigator: Aurelia Thibonnier, MD
  • Georgia
    • Augusta, Georgia, United States, 30901
      • Recruiting
      • Piedmont Augusta
      • Contact: Jennifer Hansen; Phone Number: 706-724-2463; Email: jennifer.hansen@piedmont.org
      • Principal Investigator: Houman Tamaddon, MD
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • University of Louisville
      • Contact: Leslie Haysley; Phone Number: 502-852-2801; Email: leslie.haysley@louisville.edu
      • Principal Investigator: Amit Dwivedi, MD
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland
      • Principal Investigator: Khanjan Nagarsheth, MD
      • Contact: Georges Jreij; Phone Number: 410-706-3037; Email: GJreij@som.umaryland.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham & Women's Hospital
      • Contact: Navya Kotturu; Phone Number: 617-525-8555; Email: nkotturu@bwh.harvard.edu
      • Principal Investigator: Nicholas Swerdlow, MD
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Recruiting
      • Rutgers
      • Contact: Yanille Taveras; Phone Number: 973-972-6262; Email: taveraya@njms.rutgers.edu
      • Principal Investigator: Saqib Zia, MD
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai Hospital
      • Principal Investigator: Ajit Rao, MD
      • Contact: Catherine Marin; Phone Number: 212-241-8708; Email: Catherine.Marin@mountsinai.org
    • New York, New York, United States, 10075
      • Recruiting
      • Northwell Health
      • Contact: Nhan Tran; Phone Number: 212-434-3420; Email: NNguyenTran@northwell.edu
      • Principal Investigator: Kenneth Nakazawa, MD
    • The Bronx, New York, United States, 10467
      • Recruiting
      • Montefiore Medical Center
      • Contact: Agnieszka Siemienik; Phone Number: 718-920-4539; Email: asiemien@montefiore.org
      • Principal Investigator: Saadat Shariff, MD
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Recruiting
      • Surgical Specialists of Charlotte
      • Contact: Decca Taylor; Phone Number: 704-945-3560; Email: dtaylor@ssclt.com
      • Principal Investigator: Jason Burgess, MD
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Duke University Medical Center
      • Contact: Ellen Burkett; Phone Number: 919-681-1878; Email: ellen.jones@duke.edu
      • Principal Investigator: Tristen Chun, MD
    • Raleigh, North Carolina, United States, 27610
      • Recruiting
      • WakeMed
      • Contact: Rhonda Norton; Phone Number: 919-350-5252; Email: rnorton@wakemed.org
      • Principal Investigator: Kirk Charles, MD
    • Raleigh, North Carolina, United States, 27607
      • Active, not recruiting
      • NC Heart and Vascular Research, LLC
  • Pennsylvania
    • Sayre, Pennsylvania, United States, 18840
      • Recruiting
      • Guthrie Clinic
      • Contact: Laura Warner; Phone Number: 570-887-6070; Email: Laura.Warner@guthrie.org
      • Principal Investigator: Amber Hussain, MD
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Recruiting
      • PRISMA Health- Upstate
      • Principal Investigator: Sagar Gandhi, MD
      • Contact: Maggie Salle, RN- Research Coordinator; Phone Number: 864-607-3405; Email: margaret.salle@prismahealth.org
    • Orangeburg, South Carolina, United States, 29118
      • Recruiting
      • Medical University of South Carolina
      • Contact: Virginia Anderson, RN; Phone Number: 803-395-3878; Email: vdanderson@regmed.com
      • Contact: Amy Lawson; Phone Number: 803-395-2897; Email: aclawson@regmed.com
      • Sub-Investigator: John Ross, MD
      • Principal Investigator: Mark London, MD
  • Texas
    • Dallas, Texas, United States, 75246
      • Not yet recruiting
      • Baylor Heart and Vascular
      • Contact: Katalin Martits-Chalangari; Phone Number: 214-820-1722; Email: katalin.martitschalangari@bswhealth.org
      • Contact: Mariana Hurutado; Phone Number: 214-818-6832; Email: Mariana.Hurutado@BSWHealth.org
      • Principal Investigator: Stephen Hohmann, MD
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Hopsital
      • Principal Investigator: Eric Peden, MD
      • Contact: Caroline Antunes; Phone Number: 346-238-4552; Email: cantunes@houstonmethodist.org
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington
      • Contact: Alex Ruiz; Phone Number: 206-221-3883; Email: aruiz06@uw.edu
      • Principal Investigator: Elina Quiroga, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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;	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	3, 6, 12, 18 and 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Patency Rate	Exploratory endpoint 1: Time from creation of access to first intervention to maintain patency or thrombosis	3, 6, 12, 18 and 24 months
Assisted Primary Patency Rate	Exploratory endpoint 2: Time from creation of access to first thrombosis, irrespective of intervention to maintain patency.	3, 6, 12, 18 and 24 months
Secondary Patency Rate	Exploratory endpoint 3: Time from creation of access to study graft abandonment or achievement of a censored event (death, transfer to peritoneal dialysis, renal transplant, steal, venous hypertension, or end of study period), and includes all surgical and endovascular interventions to reestablish study graft patency.	3, 6, 12, 18 and 24 months
Thrombosis rate per patient	Exploratory endpoint 4: The per patient rate of thrombosis events of the study graft at a particular timepoint.	3, 6, 12, 18 and 24 months
Proportion of subjects achieving successful cannulation among those for whom it was attempted on or before Day 7	Exploratory endpoint 5: Proportion of subjects achieving successful cannulation among those for whom it was attempted on or before Day 7, defined as the first 2-needle dialysis session through the study graft	First use of study graft
Days of central venous catheter insitu	Exploratory endpoint 6: Cumulative catheter days insitu	3, 6, 12, 18 and 24 months
Incidence of individual adverse events	Exploratory endpoint 7: cumulative adverse events, irrespective of device relatedness	3, 6, 12, 18 and 24 months
Change from baseline Patient Reported Outcomes Measures/Patient Reported Experience Measures (PROM/PREM) survey (SF-VAQ);	Exploratory endpoint 8: Change of responses over time from baseline	3, 6, 12, 18 and 24 months
Intervention rate to restore or maintain patency	Exploratory outcome 9: Intervention rate to restore or maintain patency (per patient per year)	3, 6, 12, 18 and 24 months
Health Economics data analysis	Exploratory endpoint 10: Health Economic data analysis to be performed based on available study data for the for treatment related costs (e.g. procedural costs, hospital costs, etc.)	3, 6, 12, 18 and 24 months

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: John Ross, MD, MUSC Health Dialysis Access Institute

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: December 5, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Estimated): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Failure, Chronic; Renal Insufficiency, Chronic; Surgical Procedures, Operative
• Other Study ID Numbers: CSP-2002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No