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Arteriovenous Graft
InnAVasc Graft Implant for Kidney Failure
N/A
Recruiting
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)
Age 18 to 90 years old, inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 12, 18 and 24 months
Awards & highlights
Study Summary
This trial will test whether the InnAVasc AVG is safe and works better than other standard-of-care dialysis grafts.
Who is the study for?
This trial is for adults aged 18-90 with end-stage renal failure who need a new type of arteriovenous graft for hemodialysis. Candidates should have suitable anatomy for the implant, be able to start antiplatelet therapy, and not have severe cardiac issues, uncontrolled diabetes or hypertension, recent strokes, certain blood conditions, active infections or cancer treatments within the last year.Check my eligibility
What is being tested?
The study tests the InnAVasc arteriovenous graft designed for immediate use in hemodialysis patients. It aims to reduce bleeding post-dialysis and protect against needle misplacement compared to standard dialysis grafts.See study design
What are the potential side effects?
Potential side effects may include complications at the implant site such as infection or clotting, bleeding during or after dialysis sessions due to immediate access use, and reactions related to antiplatelet therapy.
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.
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I am between 18 and 90 years old.
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I have end-stage renal disease and need an AV 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 related to InnAVasc AVG [Time Frame: through 6 months]
Secondary patency of study device at 6 months
Secondary outcome measures
Successful cannulation
Sustained use
Other outcome measures
Assisted Primary Patency Rate
Change from baseline Patient Reported Outcomes Measures/Patient Reported Experience Measures (PROM/PREM) survey (SF-VAQ);
Days of central venous catheter insitu
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Experimental: 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
26 Total Patients Enrolled
W.L.Gore & AssociatesLead Sponsor
95 Previous Clinical Trials
28,267 Total Patients Enrolled
1 Trials studying Kidney Failure
293 Patients Enrolled for Kidney Failure
Shawn Gage, PA-CStudy DirectorInnAVasc Medical
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a stroke in the last 6 months.I might have a blocked or narrowed vein where my graft is planned.The distance from my elbow crease to my armpit is less than 18 cm.You have a documented history of heparin-induced low platelet count.You have a known or suspected condition that causes blood to clot more easily than normal.I cannot or do not want to complete all required follow-ups and questionnaires.The surgeon thinks both the artery and vein are the right size, have good blood flow, and are suitable for the procedure.Your diabetes is not well controlled, and you have had to go to the hospital for diabetes-related issues many times recently.I haven't had cancer treatment in the past year, except for skin cancer.My high blood pressure is not well-controlled and has led to hospital visits.I often have very low blood pressure, especially during dialysis, which could increase my risk of blood clots in a transplant.I have HIV/AIDS or am on immunosuppressive therapy for an acute event, but chronic therapy is okay.My arm's structure allows for a specific type of graft without crossing the elbow.I have a bleeding condition not related to end-stage renal disease.I have not used any experimental drugs or devices in the last 30 days.I am not pregnant, planning to become pregnant, nursing, or planning to breastfeed during the study.I am scheduled for a kidney transplant within the next 6 months.I can start taking antiplatelet medication or am already on anticoagulation medication for a health condition.I am between 18 and 90 years old.Your platelet count is too low (less than 50,000 cells/mm3) or too high (more than 500,000 cells/mm3).I do not have severe artery problems in the limb chosen for the implant.Your hemoglobin level is lower than 7 grams per deciliter before starting the study.I had an infection, but it has been resolved for at least a week.I have end-stage renal disease and need an AV graft for dialysis.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: 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.
What is the maximum capacity for participants in this research study?
"This clinical trial necessitates 60 participants that meet the outlined criteria. Potential candidates can join from various locations, including Fayette Surgical Associates in Lexington and Greenwood Leflore Hospital in Mississippi."
Answered by AI
Is this medical trial currently accessible to individuals seeking treatment?
"Affirmative. The clinical trial is presently seeking eligible participants, with the initial posting made on December 3rd 2020 and last updated August 24th 2022. Across 4 medical institutions, a total of 60 patients are sought to partake in this study."
Answered by AI
Is the age restriction for this medical experiment confined to individuals above 55 years of age?
"This medical trial is open to patients aged 18 - 90. 54 trials are available for minors and 641 studies can be participated in by those over 65 years of age."
Answered by AI
Who meets the criteria for participating in this medical experimentation?
"This clinical trial requires 60 participants aged 18 to 90 suffering from chronic renal diseases. Admittance criteria include being suitable for the implantation of an arteriovenous graft, ability to commence antiplatelet therapy if not already taking it (anticoagulation medication is acceptable should a patient need one for their baseline medical condition), post-graft implant, and anticipation of having at least 1 year of life expectancy left."
Answered by AI
How many health centers are currently administering this clinical trial in the state?
"At present, this medical trial is running in 4 distinct sites. These include Lexington, Greenwood and Dallas with an additional site yet to be named. Consequently, it would behove potential participants to select a location that minimizes their travelling demands if they decide to join the study."
Answered by AI
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