Continued Access Study VIG Anastomotic Connector

Study Overview
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Brief Summary
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The continued access study of the InterGraft Venous Anastomotic Connector (Venous InterGraft Continued Access Study, or 'VIG-CAS') allows for continued enrollment of subjects while the marketing application is being prepared and subsequently reviewed by FDA. The VIG-CAS will include the same patient population, follow-up schedule, and study endpoints as the VIG pivotal study.

Detailed Description
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The VIG-CAS is a multicenter, prospective, single-arm study that will include up to 15 subjects contributed from up to 5 study sites that previously participated in the VIG pivotal study. No new investigators will be included. All subjects will be assigned to treatment with the VIG and a standard sutured arterial anastomosis for implantation of an arteriovenous graft (AVG) for hemodialysis. The selection criteria (patient population), follow-up schedule, and study endpoints are the same as those used in the pivotal study. Study data will be collected up to the point at which each subject has completed the final 6-month follow up or experienced a terminal study event.

Official Title
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Continued Access Study of the InterGraft™ Venous Anastomotic Connector for Minimally Invasive Connection of an Arteriovenous Graft for Hemodialysis

Conditions
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Dialysis Access Malfunction

Intervention / Treatment
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* Device: VIG Continued Access Study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is ≥ 18 years of age. Subject requires the creation of a vascular access graft for hemodialysis, secondary to a diagnosis of End Stage Renal Disease. Subject has the vascular access graft placed in an upper extremity. Baseline imaging shows suitable vascular anatomy/ vessel size for the InterGraft™ Venous Connector and an artery at least 3.5 mm in diameter that is suitable for creating the arterial anastomosis. Subject has a reasonable expectation of remaining on hemodialysis for at least 6 months. Subject or his/her legal guardian understands the study and is willing and able to comply with the dialysis schedule and follow-up requirements. Subject or his/her legal guardian provides written informed consent. NOTE: In accordance with the requirements of some Institutional Review Boards (IRBs), where applicable, only those subjects with capacity to consent for themselves will be included. Thus, where required by the IRB, adult individuals who lack capacity to consent for themselves will be excluded from the study. Physician's examination at time of surgery shows no significant vessel lesions, calcification(s), anatomic structures, or abnormalities that may limit ability to safely deploy the InterGraft™ Venous Connector or create a sutured arterial anastomosis. Exclusion Criteria: Subject has a documented and unsuccessfully treated ipsilateral central venous stenosis as determined by imaging. Subject currently has a known or suspected bacterial, fungal, or HIV infection. NOTE: Subjects with hepatitis B or C may be included in the study. Subject has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin. NOTE: The intent of this criterion is to exclude patients with high risk for bleeding or clotting complications. Patients who are taking the oral anticoagulant Eliquis® (apixaban) may be included in the study if Eliquis is temporarily discontinued prior to the study procedure, in accordance with the approved prescribing instructions. Patients may receive anticoagulation therapy any time after the study AV graft implant procedure, at their physician's discretion. This should be driven by an indication unrelated to the vascular access. Subject has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known sensitivity to heparin. Subject has co-morbid conditions that may limit their ability to comply with study and follow-up requirements. Subject has had >2 previous arteriovenous accesses in treatment arm. Subject is currently taking Aggrenox®. Subject needs or is scheduled for any major surgery within 30 days of the study procedure. Subject is currently taking maintenance immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone (>10 mg), cyclosporine, tacrolimus, or cyclophosphamide. Life expectancy is less than 12 months. Subject is pregnant. NOTE: A negative urine pregnancy test within 24 hours of the study procedure is required in all female subjects with reproductive capacity. Subject is a poor compliance risk (i.e.. history of IV or oral drug abuse). Subject is enrolled in another dialysis or vascular investigational study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VIG Continued Access<br>Patients referred for AVG implant should be screened for study eligibility. A member of the Research Team will evaluate the patient for eligibility. If all initial inclusion criteria are met and no exclusion criteria are present, a member of the Research Team should inform the patient about the study's purpose and should obtain written informed consent. Final enrollment eligibility is determined at the time of surgery, after the physician has confirmed the final inclusion criterion is met. Enrolled subjects will be assigned a unique study subject identification number. | Device: VIG Continued Access Study<br>* Small skin incisions will be made for tunneling the graft under the skin in a standard manner. The VIG device is provided pre-loaded within a customized catheter-based delivery system for over-the-wire delivery. The VIG is inserted through an introducer sheath placed in the target vein so that the 'vessel end' of the VIG is deployed within the vein, and the 'graft end' extends out of the vein for connection to the graft. Delivery and deployment will be performed under fluoroscopic guidance. The VIG will be deployed first, connected to the AVG, then the graft and VIG will be flushed and clamped. The arterial anastomosis will then be created using a standard suturing method.<br>* Other names: VIG Implant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative patency | Percentage of subjects free from loss of access of the AVG for hemodialysis | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute device success | AVG flow at the end of the procedure as determined by palpable graft thrill and/or audible bruit, without significant bleeding or emergent surgery | At implant | 
| Primary Unassisted Patency | Percentage of subjects free from the first occurrence of either access thrombosis or an access procedure performed to maintain access patency | 6 months | 
| Time to First Cannulation | Time from initial access placement to the first graft cannulation for hemodialysis | 6 months | 
| Interventions required to maintain secondary patency | Number and type of interventions required to maintain secondary patency | 6 months | 
| Number and type of Serious adverse events (SAEs) | SAEs include the following: death, emergent surgery, AVG infection requiring treatment (e.g., prolonged or intravenous antibiotic therapy), significant bleeding (defined as bleeding requiring treatment), and pseudoaneurysm | 6months |