An immediate access dialysis graft designed to prevent needle-related complications: Results from the initial pre-clinical studies.
Shawn M Gage, Michael Lawson, Craig Nichols...
https://pubmed.ncbi.nlm.nih.gov/31526086Actively Recruiting
Phase Not Applicable
Age: 18Years - 90Years
All Genders
ID04671771
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
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the InnAVasc Arteriovenous Graft (IG) for patients with end-stage renal disease (ESRD) who require hemodialysis and need an arteriovenous graft for vascular access. The study aims to measure the proportion of patients maintaining secondary patency of the graft at 6 months and to monitor adverse events related to the device during this period. Participants will receive the InnAVasc Arteriovenous Graft surgically implanted in the forearm or upper arm using standard vascular surgical techniques. The graft can be placed in a straight configuration in the upper arm or in a looped configuration in the forearm or upper arm, avoiding placement across the elbow. Patients must be able to continue or start antiplatelet therapy after the implant. The study includes periodic follow-up visits and assessments for up to two years after implantation. During the study, participants will undergo assessments to monitor graft function, safety, and successful use for hemodialysis. Researchers will collect data on device patency, adverse events, and the ability to cannulate the graft within seven days of surgery. Follow-up evaluations will continue at multiple time points up to 24 months to assess sustained graft use and patient outcomes. Participants are expected to provide informed consent and attend all scheduled visits throughout the study duration.
CONDITIONS
Brief 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
Age: 18Years - 90Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with end-stage renal disease whose next appropriate option for vascular access is placement of an arteriovenous graft to start or maintain hemodialysis
- Age between 18 and 90 years old, inclusive
- Suitable anatomy for implantation of upper arm straight or looped graft, or forearm looped graft, without crossing the bend of the elbow
- Ability to continue or start antiplatelet therapy after graft implant
- Able and willing to give informed consent
- Anticipated life expectancy of at least 1 year
- Both artery and vein vessels are appropriate for graft implantation based on the surgeon's assessment
You will not qualify if you...
- History or evidence of severe cardiac disease that may prevent study participation
- Uncontrolled diabetes with recent hospitalizations related to diabetes
- For upper arm straight graft, antecubital fossa to axillary crease distance less than 18 cm
- Severe peripheral arterial disease in the selected limb for implantation
- Known or suspected central vein stenosis or obstruction on the side of planned graft
- Baseline hypotension or frequent hypotensive episodes during dialysis increasing thrombosis risk
- Uncontrolled hypertension with recent hospitalizations
- Baseline hemoglobin less than 7 g/dL
- Baseline platelet count below 50,000 or above 500,000 cells/mm3
- History of stroke within 6 months prior to enrollment
- Treatment with investigational drug or device within 30 days prior
- Female patients who are pregnant, nursing, or intending pregnancy during study
- History of active cancer or treatment within previous year except for certain skin cancers
- Immunodeficiency or receiving immunosuppressive therapy for acute inflammation
- Known hypercoagulable condition or bleeding disorders other than related to ESRD
- History of heparin-induced thrombocytopenia
- Active infection at the time of screening
- Scheduled renal transplant within 6 months
- Any other condition that may prevent adequate evaluation of the graft
- Inability or unwillingness to complete follow-up assessments and questionnaires
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - 1 day
Participants undergo surgical implantation of the InnAVasc Arteriovenous Graft (IG) in the forearm or upper arm using standard vascular surgical techniques.
1 surgical implant visit
Post-operative Follow-up
Duration - Up to 6 months
Participants are monitored for graft patency, successful cannulation, and adverse events through follow-up visits.
Multiple follow-up visits during the 6-month period
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
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Research Team
B
Bre Lester
M
Manali Joglekar
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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Published Research Related To This Trial
Use of a novel immediate access dialysis graft designed to prevent needle-related complications: A first-in-man case report.
Shawn M Gage, Karl A Illig, John R Ross
https://pubmed.ncbi.nlm.nih.gov/32370648