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

Kidney Failure, Chronic Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03645681
• Other study ID #: CSP-1001
• Secondary ID: 2R44DK108488-02
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2, 2019
• Est. completion date: April 2025

Study information

• Verified date: May 2024
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

This clinical investigation is a prospective, multi-center, single arm, non-randomized study. Participants with ESRD who require hemodialysis and are suitable for an AVG for hemodialysis access will be eligible for inclusion in the study. Suitable participants 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). Twenty-six (26) participants will be enrolled to be implanted with the InnAVasc AVG from up to 7 investigational sites in the United States.

The primary effectiveness endpoint of secondary graft patency will be assessed at 6 months but the total study duration is 24 months. The primary safety endpoint will include characterization of dialysis graft adverse events over 6 months. It is hypothesized that the InnAVasc AVG will provide a secondary patency rate similar to the current standard of care dialysis access grafts on the market, but will have the potential to reduce needle cannulation-related adverse events and complications.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: April 2025
• Est. primary completion date: September 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Additional inclusion criteria on Day 0 (intraoperative):

• 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).

Exclusion Criteria:

• 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;

• 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

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Dialysis
• Renal Insufficiency

Intervention

Device:
• InnAVasc arteriovenous graft surgical implant
An InnAVasc AVG will be surgically implanted into the upper arm or forearm of enrolled participants

Locations

Country	Name	City	State
United States	Cardiothoracic and Vascular Surgeons	Austin	Texas
United States	Baylor Heart and Vascular Hospital	Dallas	Texas
United States	Inova Health Care Service	Falls Church	Virginia
United States	Michigan Vascular Center	Flint	Michigan
United States	Greenwood Leflore Hospital	Greenwood	Mississippi
United States	Dialysis Access Institute at the Regional Medical Center	Orangeburg	South Carolina
United States	California Institute of Renal Research	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
W.L.Gore & Associates	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Achieving Primary Patency at 3, 6, 12, 18 and 24 Months	Number of patients that have reached the timepoint without thrombosis, or intervention required to restore or maintain patency.	3, 6, 12, 18 and 24 months
Other	Number of Participants Achieving Assisted Primary Patency at 3, 6, 12, 18 and 24 Months	Number of patients that have reached the timepoint without intervention required to maintain patency.	3, 6, 12, 18 and 24 months
Other	Incidence of Individual Adverse Events	Frequency of all adverse events experience by each participant	3, 6, 12, 18 and 24 months
Other	Change From Baseline of Patient Reported Outcomes Measures / Experience Measures	Participants will complete a survey designed to assess issues around cannulation of dialysis access, technical issues, pain, anxiety.	3, 6, 12, 18 and 24 months
Other	Health Economics Derived From Collected Study Data	Overall cost to create and maintain arteriovenous (AV) access; Catheter related costs; Cost of AV access related complications	3, 6, 12, 18 and 24 months
Primary	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
Primary	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
Secondary	Number of Participants With Functional Patency of InnAVasc AVG at 3, 6, 12, 18, and 24 Months	InnAVasc AVG patent and usable for hemodialysis as defined by: AV access that can be cannulated with two dialysis needles for at least 75% of dialysis sessions within a 4- week period to achieve the prescribed dialysis	3, 6, 12, 18, and 24 months
Secondary	Time to Successful Cannulation of the InnAVasc AVG	Time from the index procedure to the first 2- needle dialysis session through the InnAVasc AVG	Observed at any point within the first 2 months post implant