Evaluating the Safety and Effectiveness of the InnAVasc Graft for Dialysis Access in Patients With Kidney Failure

NCT03645681 | Terminated Results DMC FDA Device

• 2 other identifiers: CSP-10012R44DK108488-02
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 7

Brief Summary

The CSP-1001 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.

Conditions

Kidney Failure, Chronic; Renal Dialysis

Keywords

Vascular Access; Hemodialysis Access; End Stage Renal Disease; Kidney Failure; Hemodialysis; Arteriovenous Graft; AVG; Cannulation; Quick Sealing dialysis graft

Outcome Measures

Primary Outcomes (2)

• Secondary Patency of InnAVasc AVG at 6 Months

  Secondary patency is defined as the number of patients free from abandonment, including surgical or endovascular interventions designed to reestablish AVG patency at the 6 month timepoint.

  at 6 months

• Incidence of Adverse Events of Special Interest (AESIs) Through 6 Months

  Adverse Events of special interest included: Infection of the study device, pseudoaneurysm formation at any point along the access circuit requiring surgical/endovascular intervention, including thrombin injection and compression, bleeding from the study graft requiring surgical or endovascular intervention or ≥2 units blood transfusion, hematoma from the study graft requiring surgical or endovascular intervention, seroma from the study graft requiring surgical or endovascular intervention, thrombosis of the study graft.

  through 6 months

Study Arms (1)

InnAVasc AVG treatment

EXPERIMENTAL

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

Interventions

InnAVasc arteriovenous graft surgical implant DEVICE

An InnAVasc AVG will be surgically implanted into the upper arm or forearm of enrolled participants

InnAVasc AVG treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with ESRD who are not, or who are no longer, candidates for creation of an autologous AV fistula and therefore need placement of an AV graft to start or maintain hemodialysis therapy;
• Age 18 to 80 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);
• For patients NOT on Coumadin / warfarin, international normalized ratio (INR) ≤1.5;
• Able and willing to give informed consent;
• Anticipated life expectancy of at least 1 year.
• Both vessels have been exposed and are deemed appropriate for implantation implantation (i.e. based on the surgeon's opinion, artery is of adequate size, has adequate pulse to support AV access flow and is safely clampable (i.e. artery has lack of significant calcification); and the vein is of adequate size, free of localized sclerosis, and is free of immediate outflow obstruction).

You may not qualify if:

• History or evidence of severe cardiac disease (New York Heart Association \[NYHA\] Functional Class III or IV), myocardial infarction within 6 months prior to enrollment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina;
• Diabetes with a hemoglobin A1c (HbA1c) \> 10%
• 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;
• In the opinion of the investigator, baseline hypotension, or history of frequent hypotensive episodes during dialysis that puts the patient at increased risk of graft thrombosis;
• In the opinion of the investigator, uncontrolled hypertension;
• Baseline hemoglobin \<8 g/dL;
• Baseline platelet count \<100,000 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);
• 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 state;

Sponsors & Collaborators

• W.L.Gore & Associates: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (7)

California Institute of Renal Research

San Diego, California, 92123, United States

Location

Michigan Vascular Center

Flint, Michigan, 48507, United States

Location

Greenwood Leflore Hospital

Greenwood, Mississippi, 38930, United States

Location

Dialysis Access Institute at the Regional Medical Center

Orangeburg, South Carolina, 29118-1498, United States

Location

Cardiothoracic and Vascular Surgeons

Austin, Texas, 78756, United States

Location

Baylor Heart and Vascular Hospital

Dallas, Texas, 75226, United States

Location

Inova Health Care Service

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Enrollment was terminated before enrollment was completed, and subject attrition rates prevented full analysis of endpoints.

Results Point of Contact

• Title: Bre Lester
• Organization: W. L. Gore & Associates

blester@wlgore.com

480-698-6670

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be implanted with an InnAVasc AVG in the forearm or upper arm using standard vascular surgical techniques. There are two model versions of the InnAVasc Graft. The looped model and the straight model. 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).

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 24, 2018
• Study Start: January 2, 2019
• Primary Completion: September 28, 2019
• Study Completion: January 16, 2024
• Last Updated: May 9, 2025
• Results First Posted: June 15, 2023

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)