Continued Access Study VIG Anastomotic Connector

NCT05448950 | Completed Results DMC FDA Device

• 1 other identifier: VIG-Continued Access Study
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Dialysis Access Malfunction

Outcome Measures

Primary Outcomes (1)

• Cumulative Patency

  Percentage of subjects free from loss of access of the AVG for hemodialysis

  6 months

Secondary Outcomes (5)

• Acute Device Success

  At implant

• Primary Unassisted Patency

  6 months

• Time to First Cannulation

  6 months

• Interventions Required to Maintain Secondary Patency

  6 months or up to time of early exit from the study, whichever occurs first.

• Protocol-defined Serious Adverse Events (SAEs)

  6 months or up to time of early exit from the study, whichever occurs first.

Study Arms (1)

VIG Continued Access

EXPERIMENTAL

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

Interventions

VIG Continued Access Study DEVICE

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.

Also known as: VIG Implant

VIG Continued Access

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Phraxis, Inc.: lead

Study Sites (2)

Trinity Research Group, LLC

Dothan, Alabama, 36301, United States

Location

Surgical Specialists of Charlotte

Charlotte, North Carolina, 28226, United States

Location

Related Publications (2)

• Ebner A, Ross JR, Setum CM, Kallok MJ, Yevzlin AS. Transcatheter anastomosis connector system for vascular access graft placement: results from a first-in-human pilot study. J Vasc Access. 2016 Mar-Apr;17(2):111-7. doi: 10.5301/jva.5000481. Epub 2015 Oct 7.

  PMID: 26450084 BACKGROUND

• Burgess JS, Beaver JD, London M, Rohan V, Orland P, Yevzlin A, Setum C, Ross J; InterGraft Study Investigators. Prospective multicenter study of a novel endovascular venous anastomotic procedure and device for implantation of an arteriovenous graft for hemodialysis. J Vasc Access. 2024 Jul;25(4):1244-1251. doi: 10.1177/11297298231159691. Epub 2023 Mar 9.

  PMID: 36895157 BACKGROUND

Limitations and Caveats

Enrollment terminated early due to Sponsor's transfer of device manufacturing to a new facility.

Results Point of Contact

• Title: Cindy Setum, PhD
• Organization: Phraxis, Inc.

csetum@phraxis.com

16128016730

Study Officials

• Cindy Setum, PhD

  VP of Clinical Affairs

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 8, 2022
• Study Start: June 7, 2022
• Primary Completion: March 8, 2023
• Study Completion: March 8, 2023
• Last Updated: December 4, 2024
• Results First Posted: December 4, 2024

Record last verified: 2024-11

Locations

US (2)