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

Sponsor

W.L.Gore & Associates (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03645681

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

Enrollment

Locations

Arm

26.9

Anticipated Duration (Months)

3.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Failure, Chronic Renal Dialysis	Device: InnAVasc arteriovenous graft surgical implant	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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).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).

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 :

Jan 2, 2019

Actual Primary Completion Date :

Sep 28, 2019

Anticipated Study Completion Date :

Apr 1, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

Secondary patency of InnAVasc AVG [at 6 months]
Secondary patency is defined as the time from placement of the AVG to abandonment, including surgical or endovascular interventions designed to reestablish AVG patency
Incidence of adverse events of special interest related to InnAVasc AVG [through 6 months]
Infection of the study device; Pseudoaneurysm formation at any point along the access circuit requiring surgical/endovascular intervention, including thrombin injection and compression (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); Bleeding from the study graft requiring surgical or endovascular intervention or ≥2-unit 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.

Secondary Outcome Measures

Functional patency of InnAVasc AVG [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
Time to successful cannulation of the InnAVasc AVG [Over the first 2 months post implant]
Time from the index procedure to the first 2- needle dialysis session through the InnAVasc AVG
Proportion achieving sustained use [6, 12, and 24 months]
Proportion achieving sustained use of 3 months, 6, months, 12 months, 18 months, and 24 months. Sustained use is a period of time in which the study graft is used for consecutive dialysis sessions without the requirement for alternative hemodialysis vascular access to allow for renal replacement therapy. A sustained use period can be achieved at any time throughout the study period of 24 months.

Other Outcome Measures

Primary patency rate of InnAVasc AVG [3, 6, 12, 18 and 24 months]
Time from placement to first thrombosis, or intervention to restore or maintain patency
Assisted primary patency rate of InnAVasc AVG [3, 6, 12, 18 and 24 months]
Time from placement to first intervention to maintain patency
Days of dialysis catheter in situ [3, 6, 12, 18 and 24 months]
Cumulative number of days an enrolled participant has a central venous catheter in place
Incidence of individual adverse events [3, 6, 12, 18 and 24 months]
Frequency of all adverse events experience by each participant
Change from baseline of patient reported outcomes measures / experience measures [3, 6, 12, 18 and 24 months]
Participants will complete a survey designed to assess issues around cannulation of dialysis access, technical issues, pain, anxiety.
Health Economics derived from collected study data [3, 6, 12, 18 and 24 months]
Overall cost to create and maintain arteriovenous (AV) access Catheter related costs Cost of AV access related complications

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	California Institute of Renal Research	San Diego	California	United States	92123
2	Michigan Vascular Center	Flint	Michigan	United States	48507
3	Greenwood Leflore Hospital	Greenwood	Mississippi	United States	38930
4	Dialysis Access Institute at the Regional Medical Center	Orangeburg	South Carolina	United States	29118-1498
5	Cardiothoracic and Vascular Surgeons	Austin	Texas	United States	78756
6	Baylor Heart and Vascular Hospital	Dallas	Texas	United States	75226
7	Inova Health Care Service	Falls Church	Virginia	United States	22042