Dialysis Access Malfunction
Conditions
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.
Detailed description
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.
Interventions
DEVICEVIG Continued Access Study
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.
Sponsors
Phraxis, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is ≥ 18 years of age. 2. Subject requires the creation of a vascular access graft for hemodialysis, secondary to a diagnosis of End Stage Renal Disease. 3. Subject has the vascular access graft placed in an upper extremity. 4. 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. 5. Subject has a reasonable expectation of remaining on hemodialysis for at least 6 months. 6. Subject or his/her legal guardian understands the study and is willing and able to comply with the dialysis schedule and follow-up requirements. 7. 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. 8. 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
1. Subject has a documented and unsuccessfully treated ipsilateral central venous stenosis as determined by imaging. 2. 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. 3. 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. 4. Subject has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known sensitivity to heparin. 5. Subject has co-morbid conditions that may limit their ability to comply with study and follow-up requirements. 6. Subject has had \>2 previous arteriovenous accesses in treatment arm. 7. Subject is currently taking Aggrenox®. 8. Subject needs or is scheduled for any major surgery within 30 days of the study procedure. 9. Subject is currently taking maintenance immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone (\>10 mg), cyclosporine, tacrolimus, or cyclophosphamide. 10. Life expectancy is less than 12 months. 11. 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. 12. Subject is a poor compliance risk (i.e.. history of IV or oral drug abuse). 13. Subject is enrolled in another dialysis or vascular investigational study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Patency | 6 months | Percentage of subjects free from loss of access of the AVG for hemodialysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Device Success | At implant | AVG flow at the end of the procedure as determined by palpable graft thrill and/or audible bruit, without significant bleeding or emergent surgery |
| Primary Unassisted Patency | 6 months | Percentage of subjects free from the first occurrence of either access thrombosis or an access procedure performed to maintain access patency |
| Time to First Cannulation | 6 months | Time from initial access placement to the first graft cannulation for hemodialysis |
| Interventions Required to Maintain Secondary Patency | 6 months or up to time of early exit from the study, whichever occurs first. | Number and type of interventions required to maintain secondary patency. One or more intervention-types (e.g., angioplasty, thrombectomy, etc.) may have been performed during a single intervention surgery. |
| Protocol-defined Serious Adverse Events (SAEs) | 6 months or up to time of early exit from the study, whichever occurs first. | Protocol-defined SAEs (secondary endpoint) 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. |
Countries
United States
Participant flow
Recruitment details
A total of 12 patients were enrolled during June 7, 2022, to August 26, 2022. Although the study protocol allowed for enrollment of up to 15 patients, enrollment was stopped after 12 patients were enrolled, due to Sponsor decision to transfer the device to a new manufacturing facility.
Participants by arm
| Arm | Count |
|---|---|
| VIG Continued Access Patients referred for AVG implant were screened for study eligibility by a member of the research team. If all initial inclusion criteria were met and no exclusion criteria were present, the patient was informed of the study's purpose and invited to participate. Final enrollment eligibility was determined at the time of surgery, after the investigator confirmed the final inclusion criteria were met.
Enrolled subjects were assigned a unique study subject identification number. Written informed consent was obtained from all enrolled patients prior to performing any study procedures.
VIG Continued Access Study: Small skin incisions are made for tunneling the AVG 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 manual insertion within the AVG. Delivery and deployment are performed under fluoroscopic guidance. The VIG is deployed first, connected to the AVG, then the AVG and VIG are flushed and clamped. The arterial anastomosis is then created using a standard suturing method. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | AVG abandoned | 4 |
| Overall Study | Death | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | VIG Continued Access |
|---|---|
| Age, Continuous | 60.3 years |
| Cardiovascular Disease | 6 Participants |
| Current hemodialysis access using catheter | 12 Participants |
| Diabetes mellitus | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Hyperlipidemia | 6 Participants |
| Hypertension | 12 Participants |
| Location of implant VIG (and AVG) left upper extremity | 5 Participants |
| Location of implant VIG (and AVG) right upper extremity | 7 Participants |
| Obesity | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 12 |
| other Total, other adverse events | 4 / 12 |
| serious Total, serious adverse events | 5 / 12 |
Outcome results
Primary
Cumulative Patency
Percentage of subjects free from loss of access of the AVG for hemodialysis
Time frame: 6 months
Population: Of 12 total enrolled subjects, 1 withdrew from the study before 6 months, after receiving a kidney transplant. Therefore, the number of subjects analyzed for the primary outcome measure is 11.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VIG Continued Access | Cumulative Patency | 5 Participants |
Secondary
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
Time frame: At implant
Population: The analysis population includes all subjects that received the study device (all enrolled subjects).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VIG Continued Access | Acute Device Success | 12 Participants |
Secondary
Interventions Required to Maintain Secondary Patency
Number and type of interventions required to maintain secondary patency. One or more intervention-types (e.g., angioplasty, thrombectomy, etc.) may have been performed during a single intervention surgery.
Time frame: 6 months or up to time of early exit from the study, whichever occurs first.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VIG Continued Access | Interventions Required to Maintain Secondary Patency | angioplasty | 12 Type of intervention |
| VIG Continued Access | Interventions Required to Maintain Secondary Patency | thrombectomy | 10 Type of intervention |
| VIG Continued Access | Interventions Required to Maintain Secondary Patency | thrombolytic infusion | 1 Type of intervention |
| VIG Continued Access | Interventions Required to Maintain Secondary Patency | stent placement | 3 Type of intervention |
Secondary
Primary Unassisted Patency
Percentage of subjects free from the first occurrence of either access thrombosis or an access procedure performed to maintain access patency
Time frame: 6 months
Population: Of 12 total enrolled subjects, 1 withdrew from the study before 6 months, after receiving a kidney transplant. Therefore, the number of subjects analyzed for the primary outcome measure is 11.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VIG Continued Access | Primary Unassisted Patency | 4 Participants |
Secondary
Protocol-defined Serious Adverse Events (SAEs)
Protocol-defined SAEs (secondary endpoint) 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.
Time frame: 6 months or up to time of early exit from the study, whichever occurs first.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VIG Continued Access | Protocol-defined Serious Adverse Events (SAEs) | No protocol-defined SAEs | 9 Participants |
| VIG Continued Access | Protocol-defined Serious Adverse Events (SAEs) | Death | 2 Participants |
| VIG Continued Access | Protocol-defined Serious Adverse Events (SAEs) | AVG infection | 1 Participants |
| VIG Continued Access | Protocol-defined Serious Adverse Events (SAEs) | Emergent surgery | 0 Participants |
| VIG Continued Access | Protocol-defined Serious Adverse Events (SAEs) | Significant bleeding | 0 Participants |
| VIG Continued Access | Protocol-defined Serious Adverse Events (SAEs) | Pseudoaneurysm | 0 Participants |
Secondary
Time to First Cannulation
Time from initial access placement to the first graft cannulation for hemodialysis
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| VIG Continued Access | Time to First Cannulation | 27.6 days |