A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access

• ClinicalTrials.gov Identifier: NCT04671771
• Recruitment Status: Recruiting
• First Posted: December 17, 2020
• Last Update Posted: April 19, 2021
• Sponsor: InnAVasc Medical, Inc.
• Information provided by (Responsible Party): InnAVasc Medical, Inc.

Study Description

Brief Summary:

The CSP-2002 study will evaluate the safety and effectiveness of the InnAVasc arteriovenous graft (AVG) when implanted in and used for hemodialysis in participants suffering from end-stage renal failure (ESRD). The InnAVasc AVG is implanted and used similar to other standard-of-care dialysis grafts currently on the market. However, the InnAVasc AVG has been uniquely designed to potentially allow for immediate needle access (same day as implant surgery as opposed to 2-4 weeks of waiting), to potentially reduce excessive bleeding from the graft after dialysis, and it may provide protection from improper or missed needle cannulation attempts.

Condition or disease	Intervention/treatment	Phase
End Stage Renal Disease (ESRD); Kidney Failure; Chronic Renal Disease	Device: InnAVasc arteriovenous graft surgical implant	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: A prospective, multi-center, single-arm study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: December 3, 2020
• Estimated Primary Completion Date: October 22, 2022
• Estimated Study Completion Date: August 1, 2023

Arms and Interventions

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).	Device: InnAVasc arteriovenous graft surgical implant; 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

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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:

   1. Infection of the study graft;
   2. Pseudoaneurysm formation at any point a long the study graft requiring surgical or endovascular intervention(pseudoaneurysms that occur at sites of needle cannulation, but which are small enough to be observed without intervention, do not trigger this element of the AESI endpoint);
   3. Bleeding from the study graft requiring surgical or endovascular intervention or ≥ 2-unit blood transfusion;
   4. Hematoma from the study graft requiring surgical or endovascular intervention;
   5. Seroma of the study graft requiring surgical or endovascular intervention;
   6. Thrombosis of the study graft.

Secondary Outcome Measures :

1. 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
2. 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.

Other Outcome Measures:

1. 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
2. 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. Days of central venous catheter insitu [ Time Frame: 3, 6, 12, 18 and 24 months ]
   Exploratory endpoint 3: Cumulative catheter days insitu
4. Incidence of individual adverse events [ Time Frame: 3, 6, 12, 18 and 24 months ]
   Exploratory endpoint 4: cumulative adverse events, irrespective of device relatedness
5. 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
6. 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.)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

Pre-operative Inclusion Criteria

1. Patients with ESRD whose next most appropriate option for AV access is placement of an AV graft to start or maintain hemodialysis therapy;
2. Age 18 to 90 years old, inclusive;
3. Suitable anatomy for implantation of upper arm "straight" or looped graft, or forearm looped graft (graft not to cross the bend of the elbow);
4. 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;
5. Able and willing to give informed consent;
6. 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:

1. 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;
2. Uncontrolled diabetes in the opinion of the investigator (i.e., multiple recent diabetes related hospitalizations);
3. For upper arm straight configuration, antecubital fossa crease to axillary crease distance < 18 cm;
4. History or evidence of severe peripheral arterial disease in the extremity selected for implant (i.e., arterial inflow insufficient to support hemodialysis access);
5. Known or suspected central vein stenosis or obstruction on the side of planned graft implantation;
6. 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;
7. Uncontrolled hypertension, per the opinion of the investigator (i.e., recent history of recurrent hospitalizations for hypertensive related illness);
8. Baseline hemoglobin <7 g/dL;
9. Baseline platelet count <50,000 or >500,000 cells/mm3;
10. Documented history of stroke within 6 months prior to enrollment;
11. Treatment with any investigational drug or device within 30 days prior to enrollment;
12. 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);
13. History of cancer with active disease or treatment within the previous year, except for non-invasive basal or squamous cell carcinoma of the skin;
14. 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;
15. Documented or suspected hypercoagulable condition;
16. Bleeding diathesis, other than that associated with ESRD;
17. Documented history of heparin-induced thrombocytopenia (HIT);
18. 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;
19. Scheduled renal transplant within 6 months;
20. Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and effectiveness of the InnAVasc AVG;
21. 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:

1. 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;
2. Uncontrolled diabetes in the opinion of the investigator (i.e., multiple recent diabetes related hospitalizations);
3. For upper arm straight configuration, antecubital fossa crease to axillary crease distance < 18 cm;
4. History or evidence of severe peripheral arterial disease in the extremity selected for implant (i.e., arterial inflow insufficient to support hemodialysis access);
5. Known or suspected central vein stenosis or obstruction on the side of planned graft implantation;
6. 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;
7. Uncontrolled hypertension, per the opinion of the investigator (i.e., recent history of recurrent hospitalizations for hypertensive related illness);
8. Baseline hemoglobin <7 g/dL;

Contacts and Locations

Contacts

Contact: Shawn M Gage, PA-C; +19194524686; shawn.gage@innavasc.com

Contact: Craig Nichols; +13023732604; craig.nichols@innavasc.com

Locations

United States, Kentucky

Fayette Surgical Associates; Recruiting

Lexington, Kentucky, United States, 40504

Contact: Amanda Gaddis 859-278-4960 gaddisak@yahoo.com

Principal Investigator: Colby Atkins, MD

United States, Mississippi

Greenwood Leflore Hospital; Recruiting

Greenwood, Mississippi, United States, 38930

Contact: Rebecca McGlawn 662-299-2216 rmcglawn@glh.org

Principal Investigator: John Lucas, MD

United States, South Carolina

Dialysis Access Institute; Not yet recruiting

Orangeburg, South Carolina, United States, 29118

Contact: Virginia Anderson, RN 803-395-3878 vdanderson@regmed.com

Contact: Amy Lawson 803-395-2897 aclawson@regmed.com

Principal Investigator: Mark Loondon, MD

Sub-Investigator: John Ross, MD

United States, Texas

Baylor Heart and Vascular; Recruiting

Dallas, Texas, United States, 75246

Contact: Katalin Martits-Chalangari 214-820-1722 katalin.martitschalangari@bswhealth.org

Contact: Mariana Hurutado 214-818-6832 Mariana.Hurutado@BSWHealth.org

Principal Investigator: Stephen Hohmann, MD

Sub-Investigator: John Eidt, MD

Sponsors and Collaborators

InnAVasc Medical, Inc.

Investigators

• Study Director: Shawn Gage, PA-C; InnAVasc Medical

More Information

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.

• Responsible Party: InnAVasc Medical, Inc.
• ClinicalTrials.gov Identifier: NCT04671771
• Other Study ID Numbers: CSP-2002
• First Posted: December 17, 2020
• Last Update Posted: April 19, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Additional relevant MeSH terms:

Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency; Renal Insufficiency, Chronic; Urologic Diseases