- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04671771
A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access
A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
Study Overview
Status
Intervention / Treatment
Detailed Description
The InnAVasc AVG is intended for use in ESRD hemodialysis patients who require HD and whose next most appropriate access is an AVG, also including those who may require an immediate cannulation AVG.
Patients with ESRD who require hemodialysis and are suitable for an AVG for hemodialysis access will be eligible for inclusion in the study. Subjects will be 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). Placing the graft across the elbow will be prohibited. Subjects must be able to be on antiplatelet therapy per the discretion of their physician (i.e., aspirin, clopidogrel, etc.).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shawn M Gage, PA-C
- Phone Number: +19194524686
- Email: shawn.gage@innavasc.com
Study Contact Backup
- Name: Craig Nichols
- Phone Number: +13023732604
- Email: craig.nichols@innavasc.com
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40504
- Recruiting
- Fayette Surgical Associates
-
Contact:
- Amanda Gaddis
- Phone Number: 859-278-4960
- Email: gaddisak@yahoo.com
-
Principal Investigator:
- Colby Atkins, MD
-
-
Mississippi
-
Greenwood, Mississippi, United States, 38930
- Recruiting
- Greenwood Leflore Hospital
-
Contact:
- Rebecca McGlawn
- Phone Number: 662-299-2216
- Email: rmcglawn@glh.org
-
Principal Investigator:
- John Lucas, MD
-
-
South Carolina
-
Orangeburg, South Carolina, United States, 29118
- Not yet recruiting
- Dialysis Access Institute
-
Contact:
- Virginia Anderson, RN
- Phone Number: 803-395-3878
- Email: vdanderson@regmed.com
-
Contact:
- Amy Lawson
- Phone Number: 803-395-2897
- Email: aclawson@regmed.com
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Principal Investigator:
- Mark Loondon, MD
-
Sub-Investigator:
- John Ross, MD
-
-
Texas
-
Dallas, Texas, United States, 75246
- Recruiting
- Baylor Heart and Vascular
-
Contact:
- Katalin Martits-Chalangari
- Phone Number: 214-820-1722
- Email: katalin.martitschalangari@bswhealth.org
-
Contact:
- Mariana Hurutado
- Phone Number: 214-818-6832
- Email: Mariana.Hurutado@BSWHealth.org
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Sub-Investigator:
- John Eidt, MD
-
Principal Investigator:
- Stephen Hohmann, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Pre-operative Inclusion Criteria
- 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 commence antiplatelet therapy if the subject is not already taking (anticoagulation medication is acceptable if the subject is required to take an anticoagulant for a baseline medical condition), post graft implant;
- Able and willing to give informed consent;
- Anticipated life expectancy of at least 1 year.
Intra-operative Inclusion Criteria
1. 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).
Exclusion Criteria:
Patients will be excluded from the study for:
- 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, 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;
- Bleeding diathesis, other than that associated with ESRD;
- Documented history of heparin-induced thrombocytopenia (HIT);
- Active local or systemic infection as documented from the medical history or bloodwork / blood culture data. If the infection resolves, the subject must be at least one-week post resolution of that infection before implantation;
- Scheduled renal transplant within 6 months;
- Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and effectiveness of the InnAVasc AVG;
- Patient is unable or unwilling to complete all required follow-up assessments and questionnaires.
Exclusion Criteria:
Pre-operative Exclusion Criteria:
Patients will be excluded from the study for:
- 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, 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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: InnAVasc AVG treatment
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).
|
The InnAVasc AVG is a hemodialysis vascular access graft, intended for implantation in the lower or upper arm using standard vascular techniques, in patients requiring hemodialysis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary patency of study device at 6 months
Time Frame: 6 months
|
This is the Primary Effectiveness Endpoint Outcome for the study.
This outcome is measured as the proportion of subjects with secondary patency (i.e.
not abandoned) at 6 months.
|
6 months
|
Incidence of adverse events of special interest related to InnAVasc AVG [Time Frame: through 6 months]
Time Frame: 6 months
|
This is the Primary Safety Outcome in the study. Incidence of adverse events of special interest (device-related AESIs) are adverse events that are most clinically relevant to hemodialysis access. AESIS are as follows:
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Successful cannulation
Time Frame: 7 days
|
Proportion of subjects achieving successful cannulation on or before day 7, defined as the first 2-needle dialysis session through the study graft
|
7 days
|
Sustained use
Time Frame: 3, 6, 12, 18 and 24 months
|
Proportion of subjects achieving sustained use of 3 months,6, months, 12 months, 18 months, and 24 months.
|
3, 6, 12, 18 and 24 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Patency Rate
Time Frame: 3, 6, 12, 18 and 24 months
|
Exploratory endpoint 1: Time from creation of access to first intervention to maintain patency or thrombosis
|
3, 6, 12, 18 and 24 months
|
Assisted Primary Patency Rate
Time Frame: 3, 6, 12, 18 and 24 months
|
Exploratory endpoint 2: Time from creation of access to first thrombosis, irrespective of intervention to maintain patency.
|
3, 6, 12, 18 and 24 months
|
Days of central venous catheter insitu
Time Frame: 3, 6, 12, 18 and 24 months
|
Exploratory endpoint 3: Cumulative catheter days insitu
|
3, 6, 12, 18 and 24 months
|
Incidence of individual adverse events
Time Frame: 3, 6, 12, 18 and 24 months
|
Exploratory endpoint 4: cumulative adverse events, irrespective of device relatedness
|
3, 6, 12, 18 and 24 months
|
Change from baseline Patient Reported Outcomes Measures/Patient Reported Experience Measures (PROM/PREM) survey (SF-VAQ);
Time Frame: 3, 6, 12, 18 and 24 months
|
Exploratory endpoint 5: Change of responses over time from baseline
|
3, 6, 12, 18 and 24 months
|
Health Economics data analysis
Time Frame: 3, 6, 12, 18 and 24 months
|
Exploratory endpoint 6: Health Economic data analysis to be performed based on available study data for the for treatment related costs (e.g.
procedural costs, hospital costs, etc.)
|
3, 6, 12, 18 and 24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Shawn Gage, PA-C, InnAVasc Medical
Publications and helpful links
General Publications
- 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.
- Gage 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSP-2002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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