Actively Recruiting
A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
Led by W.L.Gore & Associates · Updated on 2025-12-22
133
Participants Needed
21
Research Sites
447 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with end-stage renal disease whose next appropriate access is an arteriovenous graft for hemodialysis
- Age 18 to 90 years old, inclusive
- Suitable anatomy for upper arm straight or looped graft, or forearm looped graft (graft must not cross the elbow)
- Ability to continue or start antiplatelet therapy after graft implant
- Able and willing to provide informed consent
- Expected to live at least 1 year
- Both vessels exposed and suitable for implantation based on surgeon's evaluation
You will not qualify if you...
- History or evidence of severe cardiac disease that may prevent study participation
- Uncontrolled diabetes as judged by investigator
- Upper arm straight graft placement not possible if antecubital to axillary crease distance is less than 18 cm
- Severe peripheral arterial disease in the limb planned for implant
- Known or suspected central vein blockage on the implant side
- Baseline low blood pressure or frequent hypotension during dialysis increasing thrombosis risk
- Uncontrolled hypertension with recent hospitalizations
- Baseline hemoglobin below 7 g/dL
- Baseline platelet count below 50,000 or above 500,000 cells/mm3
- Stroke history within 6 months prior to enrollment
- Use of investigational drug or device within 30 days before enrollment
- Female patients who are pregnant, planning pregnancy, nursing, or breastfeeding unless post-menopausal or surgically sterile
- Active cancer or treatment within the last year except non-invasive skin cancers
- Immunodeficiency including HIV/AIDS or recent immunosuppressive therapy for acute events
- Known or suspected hypercoagulable conditions
- Bleeding disorders other than those related to ESRD
- History of heparin-induced thrombocytopenia
- Active infections until resolved for at least one week
- Scheduled kidney transplant within 6 months
- Any other condition that would prevent proper evaluation of the device
- Inability or unwillingness to complete all follow-up visits and questionnaires
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
AKDHC Medical Research Services, LLC
Phoenix, Arizona, United States, 85012
Actively Recruiting
2
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
Actively Recruiting
3
University of South Florida
Tampa, Florida, United States, 33606
Actively Recruiting
4
Piedmont Augusta
Augusta, Georgia, United States, 30901
Actively Recruiting
5
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
6
University of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
7
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
8
Rutgers
Newark, New Jersey, United States, 07103
Actively Recruiting
9
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
10
Northwell Health
New York, New York, United States, 10075
Actively Recruiting
11
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
12
Surgical Specialists of Charlotte
Charlotte, North Carolina, United States, 28204
Actively Recruiting
13
Duke University Medical Center
Durham, North Carolina, United States, 27705
Actively Recruiting
14
NC Heart and Vascular Research, LLC
Raleigh, North Carolina, United States, 27607
Active, Not Recruiting
15
WakeMed
Raleigh, North Carolina, United States, 27610
Actively Recruiting
16
Guthrie Clinic
Sayre, Pennsylvania, United States, 18840
Actively Recruiting
17
Prisma Health- Upstate
Greenville, South Carolina, United States, 29615
Actively Recruiting
18
Medical University of South Carolina
Orangeburg, South Carolina, United States, 29118
Actively Recruiting
19
Baylor Heart and Vascular
Dallas, Texas, United States, 75246
Not Yet Recruiting
20
Houston Methodist Hopsital
Houston, Texas, United States, 77030
Actively Recruiting
21
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
B
Bre Lester
CONTACT
M
Manali Joglekar
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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