Clinical Evaluation of a Vascular Venous Anastomotic Connector (02532621) (Phraxis InterGraft Study)
Clinical Evaluation of a Vascular Venous Anastomotic Connector for Minimally Invasive Connection of an Arteriovenous Graft for Hemodialysis
The InterGraft™ Venous Anastomotic Connector provides a minimally invasive, sutureless method for attachment of an arteriovenous graft to a vein in the upper extremity. The InterGraft™ Venous Anastomotic Connector facilitates creation of the arteriovenous graft connection to a vein in support of hemodialysis in subjects with End Stage Renal Disease. The InterGraft™ Venous Anastomotic Connector is used together with conventional suturing of the arterial anastomosis to facilitate creation of an arteriovenous graft in support of hemodialysis in subjects with End Stage Renal Disease.
Key Inclusion Criteria
For a patient to be eligible for participation in this study, all of the following criteria must apply.
- 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 is able to have 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, where applicable, only those subjects with capacity to consent for themselves will be included. Thus, where required by the Institutional Review Board, 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 Connectors or create a sutured arterial anastomosis.
Key Exclusion Criteria
A patient will not be eligible for participation in this study if any of the following criteria apply.
- 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: Patients 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. As such, patients who are taking oral anticoagulants (blood thinners) including, but not limited to, Xarelto® (rivaroxaban) or Eliquis® (apixaban) should also be excluded from the study. 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.
- The patient has had >2 previous arteriovenous accesses in treatment arm.
- Subject is currently taking Aggrenox®.
- Subject is in need of, 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).
- The subject is enrolled in another dialysis or vascular investigational study.
To learn more, visit ClinicalTrials.Gov
Ari Kramer, MD