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Arteriovenous Graft
InnAVasc Graft for Kidney Failure
N/A
Waitlist Available
Research Sponsored by InnAVasc Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Suitable anatomy for implantation of upper arm 'straight' or looped graft, or forearm looped graft (graft not to cross the bend of the elbow)
For patients NOT on Coumadin / warfarin, international normalized ratio (INR) ≤1.5
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 12, 18 and 24 months
Awards & highlights
Study Summary
This trial will study if a new kind of dialysis access graft is safe and effective. The new graft has been designed to allow for immediate needle access, reduce excessive bleeding, and provide protection from improper needle cannulation attempts.
Who is the study for?
This trial is for adults aged 18-80 with end-stage renal failure who need a dialysis graft but can't have an autologous fistula. Candidates should have suitable anatomy for the graft, not be on strong blood thinners, and expect to live at least another year. Exclusions include severe heart disease, uncontrolled diabetes or hypertension, recent stroke or myocardial infarction, active infections or cancer treatment within a year (except certain skin cancers), and known clotting disorders.Check my eligibility
What is being tested?
The study tests the InnAVasc arteriovenous graft's safety and effectiveness in hemodialysis patients with kidney failure. This new type of graft may allow immediate use after surgery, potentially reduce bleeding post-dialysis, and offer protection against needle misplacement compared to standard dialysis grafts.See study design
What are the potential side effects?
Potential side effects could include complications from surgery such as infection or bleeding at the implant site. There might also be issues related to dialysis like clotting of the new graft or problems due to incorrect needle placement during dialysis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My arm's structure allows for a specific type of graft without crossing the elbow.
Select...
My blood clotting time is normal and I'm not on Coumadin/warfarin.
Select...
I have end-stage renal disease and cannot have a natural fistula, so I need an artificial graft for dialysis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, 6, 12, 18 and 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 12, 18 and 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events of Special Interest (AESIs) Through 6 Months
Secondary Patency of InnAVasc AVG at 6 Months
Secondary outcome measures
Number of Participants With Functional Patency of InnAVasc AVG at 3, 6, 12, 18, and 24 Months
Time to Successful Cannulation of the InnAVasc AVG
Other outcome measures
Change From Baseline of Patient Reported Outcomes Measures / Experience Measures
Health Economics Derived From Collected Study Data
Incidence of Individual Adverse Events
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: InnAVasc AVG treatmentExperimental Treatment1 Intervention
Patients will be surgically implanted with an InnAVasc AVG 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).
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Who is running the clinical trial?
InnAVasc Medical, Inc.Lead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
W.L.Gore & AssociatesLead Sponsor
95 Previous Clinical Trials
28,307 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,357 Previous Clinical Trials
4,315,160 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I might have a blocked or narrowed vein where my graft is planned.Your platelet count is either too low (less than 100,000) or too high (more than 500,000).I haven't used any experimental drugs or devices in the last 30 days.I haven't had cancer treatment in the past year, except for non-invasive skin cancer.My diabetes is severe with an HbA1c over 10%.I do not have severe heart problems or recent heart attacks.I do not currently have an infection, or if I did, it has been resolved for at least a week.I am scheduled for a kidney transplant within the next 6 months.I am between 18 and 80 years old.My arm's structure allows for a specific type of graft without crossing the elbow.I have severe artery problems in the limb chosen for my medical device.I had a stroke within the last 6 months.I am not pregnant, planning to become pregnant, nursing, or planning to breastfeed during the study.I have a history of HIV/AIDS or am on immunosuppressive therapy for an acute event.You have a known or suspected condition that makes your blood more likely to clot.I have a bleeding condition not related to kidney failure.The doctor thinks that you have a condition that would make it hard to check how the treatment is working.My blood clotting time is normal and I'm not on Coumadin/warfarin.My surgeon confirmed my blood vessels are suitable for the implant.You have had a confirmed case of heparin-induced thrombocytopenia (HIT) in the past.The distance from my elbow crease to my armpit is less than 18 cm.The doctor thinks you have low blood pressure or have had frequent low blood pressure episodes during dialysis, which could increase the risk of blood clots in the transplant.I have end-stage renal disease and cannot have a natural fistula, so I need an artificial graft for dialysis.You are expected to live for at least 1 year.Your hemoglobin level is lower than 8 grams per deciliter before starting the trial.
Research Study Groups:
This trial has the following groups:- Group 1: InnAVasc AVG treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are a multitude of healthcare facilities currently running this research study in the state?
"For this trial, Baylor Heart and Vascular Hospital in Dallas is recruiting patients as well as California Institute of Renal Research in San Diego. Cardiothoracic and Vascular Surgeons from Austin are likewise enrolling participants alongside 7 additional sites across the nation."
Answered by AI
Is the age limit for trial participation younger than seventy-five years?
"Eligible participants for this medical trial must be aged between 18 and 80 years. Separately, there are 17 studies available to individuals below the age of majority, while 283 clinical trials target patients over 65 years old."
Answered by AI
What criteria must a person fulfill to participate in this research?
"To be considered for inclusion in this trial, participants must have renal dialysis and fall between the ages of 18 to 80. This research project is recruiting a maximum of 26 individuals."
Answered by AI
Is this experiment now enrolling participants?
"The clinicaltrials.gov entry for this experimental medical trial confirms that it is not seeking out new candidates at the moment, having been initially posted on January 2nd 2019 and last updated on August 24th 2022. Nevertheless, 294 other clinical trials are actively recruiting patients right now."
Answered by AI
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