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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Patency | Percentage of subjects free from loss of access of the AVG for hemodialysis | 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cindy Setum, PhD | VP of Clinical Affairs | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trinity Research Group, LLC | Dothan | Alabama | 36301 | United States | ||
| Surgical Specialists of Charlotte |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26450084 | Background | 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. | |
| 36895157 | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cumulative Patency | Percentage of subjects free from loss of access of the AVG for hemodialysis | 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. | Posted | Count of Participants | Participants | 6 months |
|
Adverse event information was collected over a 6 month follow up period, or up to the date of a terminal study event (e.g., death, AVG abandonment, subject withdrawal), up to 6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pneumonia, requiring hospitalization | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pain | General disorders | Systematic Assessment |
Enrollment terminated early due to Sponsor's transfer of device manufacturing to a new facility.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cindy Setum, PhD | Phraxis, Inc. | 16128016730 | csetum@phraxis.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 15, 2022 | Apr 17, 2024 | Prot_SAP_000.pdf |
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|
|
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. One or more intervention-types (e.g., angioplasty, thrombectomy, etc.) may have been performed during a single intervention surgery. | 6 months or up to time of early exit from the study, whichever occurs first. |
| 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. | 6 months or up to time of early exit from the study, whichever occurs first. |
| Charlotte |
| North Carolina |
| 28226 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diabetes mellitus | Count of Participants | Participants |
|
| Obesity | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Cardiovascular Disease | Count of Participants | Participants |
|
| Hyperlipidemia | Count of Participants | Participants |
|
| Current hemodialysis access using catheter | Count of Participants | Participants |
|
| Location of implant VIG (and AVG) | Count of Participants | 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 | The analysis population includes all subjects that received the study device (all enrolled subjects). | Posted | Count of Participants | Participants | At implant |
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Time to First Cannulation | Time from initial access placement to the first graft cannulation for hemodialysis | Posted | Mean | Full Range | days | 6 months |
|
|
|
| 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. | Posted | Number | Type of intervention | 6 months or up to time of early exit from the study, whichever occurs first. | intervention surgeries | intervention surgeries |
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 months or up to time of early exit from the study, whichever occurs first. |
|
|
|
| 2 |
| 12 |
| 5 |
| 12 |
| 4 |
| 12 |
| hematoma | Vascular disorders | Systematic Assessment | Hematoma developed at needle puncture site (vascular access) on the AVG, causing damage to the AVG and necrosis in overlying skin. Treatment included excision of the mid-portion of the AVG. |
|
| cardiac arrest | Cardiac disorders | Systematic Assessment | Subject had out of hospital cardiac arrest. CPR was provided and ROSC was obtained. Subject was transferred for comfort care, followed with subsequent death. |
|
| infection of AVG | Infections and infestations | Systematic Assessment |
|
| abscess, tooth | Infections and infestations | Systematic Assessment | abscess of tooth, subject hospitalized for treatment |
|
| cardiac arrest | Cardiac disorders | Systematic Assessment | Subject had cardiac arrest while receiving hemodialysis. Despite resuscitation efforts, death occurred. |
|
| COVID-19 | Infections and infestations | Systematic Assessment | The study protocol required that subjects with positive COVID-19 test be reported as an AE. |
|
| inflammation | General disorders | Systematic Assessment | inflammation/redness at surgical incision site for AVG placement. |
|
| cancer, skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| bruising following a fall | General disorders | Systematic Assessment |
|
| bleeding, minor | General disorders | Systematic Assessment | minor bleeding at skin (incision) edge following AVG implantation procedure |
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Agreement states the following:
Research results and associated data generated by this Study conducted under this Agreement will be considered confidential until the first publication or presentation thereof of data according to the terms of this Agreement or one (1) year after conclusion, abandonment or termination of the Study.
| Title | Measurements |
|---|---|
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| stent placement |
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| Significant bleeding |
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| Pseudoaneurysm |
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| No protocol-defined SAEs |
|