A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
1 other identifier
interventional
133
1 country
21
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2020
Longer than P75 for not_applicable
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 3, 2020
CompletedFirst Submitted
Initial submission to the registry
December 5, 2020
CompletedFirst Posted
Study publicly available on registry
December 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2029
December 22, 2025
December 1, 2025
7 years
December 5, 2020
December 18, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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: 1. Infection of the study graft; 2. 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); 3. Bleeding from the study graft requiring surgical or endovascular intervention or ≥2-unit blood transfusion; 4. Hematoma from the study graft requiring surgical or endovascular intervention; 5. Seroma of the study graft requiring surgical or endovascular intervention;
6 months
Secondary Outcomes (2)
Successful cannulation on or before Postoperative Day 7
7 days
Sustained use
3, 6, 12, 18 and 24 months
Other Outcomes (10)
Primary Patency Rate
3, 6, 12, 18 and 24 months
Assisted Primary Patency Rate
3, 6, 12, 18 and 24 months
Secondary Patency Rate
3, 6, 12, 18 and 24 months
- +7 more other outcomes
Study Arms (1)
Experimental: InnAVasc AVG treatment
EXPERIMENTALPatients 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).
Interventions
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
You may qualify if:
- 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.
- 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).
You may not qualify if:
- 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;
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
AKDHC Medical Research Services, LLC
Phoenix, Arizona, 85012, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
University of South Florida
Tampa, Florida, 33606, United States
Piedmont Augusta
Augusta, Georgia, 30901, United States
University of Louisville
Louisville, Kentucky, 40202, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Rutgers
Newark, New Jersey, 07103, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Northwell Health
New York, New York, 10075, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Surgical Specialists of Charlotte
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
NC Heart and Vascular Research, LLC
Raleigh, North Carolina, 27607, United States
WakeMed
Raleigh, North Carolina, 27610, United States
Guthrie Clinic
Sayre, Pennsylvania, 18840, United States
Prisma Health- Upstate
Greenville, South Carolina, 29615, United States
Medical University of South Carolina
Orangeburg, South Carolina, 29118, United States
Baylor Heart and Vascular
Dallas, Texas, 75246, United States
Houston Methodist Hopsital
Houston, Texas, 77030, United States
University of Washington
Seattle, Washington, 98195, United States
Related Publications (2)
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.
PMID: 31526086BACKGROUNDGage 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.
PMID: 32370648BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Ross, MD
MUSC Health Dialysis Access Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2020
First Posted
December 17, 2020
Study Start
December 3, 2020
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
July 1, 2029
Last Updated
December 22, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share