Trial Outcomes & Findings for Continued Access Study VIG Anastomotic Connector (NCT NCT05448950)

NCT ID: NCT05448950

Last Updated: 2024-12-04

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2024-12-04

Participant Flow

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.

Participant milestones

Measure	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.
Overall Study STARTED	12
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	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.
Overall Study Death	2
Overall Study Withdrawal by Subject	1
Overall Study AVG abandoned	4

Baseline Characteristics

Continued Access Study VIG Anastomotic Connector

Baseline characteristics by cohort

Measure	VIG Continued Access n=12 Participants 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.
Age, Continuous	60.3 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants
Diabetes mellitus	4 Participants n=5 Participants
Obesity	2 Participants n=5 Participants
Hypertension	12 Participants n=5 Participants
Cardiovascular Disease	6 Participants n=5 Participants
Hyperlipidemia	6 Participants n=5 Participants
Current hemodialysis access using catheter	12 Participants n=5 Participants
Location of implant VIG (and AVG) left upper extremity	5 Participants n=5 Participants
Location of implant VIG (and AVG) right upper extremity	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Measure

VIG Continued Access n=11 Participants 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.

Cumulative Patency

5 Participants

SECONDARY outcome

Timeframe: At implant

Population: The analysis population includes all subjects that received the study device (all enrolled subjects).

AVG flow at the end of the procedure as determined by palpable graft thrill and/or audible bruit, without significant bleeding or emergent surgery

Outcome measures

Measure

VIG Continued Access n=12 Participants 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.

Acute Device Success

12 Participants

SECONDARY outcome

Timeframe: 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.

Percentage of subjects free from the first occurrence of either access thrombosis or an access procedure performed to maintain access patency

Outcome measures

Measure

VIG Continued Access n=11 Participants 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.

Primary Unassisted Patency

4 Participants

SECONDARY outcome

Timeframe: 6 months

Time from initial access placement to the first graft cannulation for hemodialysis

Outcome measures

Measure

VIG Continued Access n=12 Participants 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.

Time to First Cannulation

27.6 days Interval 9.0 to 50.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	VIG Continued Access n=26 intervention surgeries 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.
Interventions Required to Maintain Secondary Patency angioplasty	12 Type of intervention
Interventions Required to Maintain Secondary Patency thrombectomy	10 Type of intervention
Interventions Required to Maintain Secondary Patency thrombolytic infusion	1 Type of intervention
Interventions Required to Maintain Secondary Patency stent placement	3 Type of intervention

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	VIG Continued Access n=12 Participants 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.
Protocol-defined Serious Adverse Events (SAEs) AVG infection	1 Participants
Protocol-defined Serious Adverse Events (SAEs) Death	2 Participants
Protocol-defined Serious Adverse Events (SAEs) Emergent surgery	0 Participants
Protocol-defined Serious Adverse Events (SAEs) Significant bleeding	0 Participants
Protocol-defined Serious Adverse Events (SAEs) Pseudoaneurysm	0 Participants
Protocol-defined Serious Adverse Events (SAEs) No protocol-defined SAEs	9 Participants

Adverse Events

VIG Continued Access

Serious events: 5 serious events

Other events: 4 other events

Deaths: 2 deaths

Serious adverse events

Measure	VIG Continued Access n=12 participants at risk 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.
Respiratory, thoracic and mediastinal disorders pneumonia, requiring hospitalization	8.3% 1/12 • Number of events 2 • 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.
Vascular disorders hematoma	8.3% 1/12 • Number of events 1 • 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.
Cardiac disorders cardiac arrest	8.3% 1/12 • Number of events 1 • 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.
Infections and infestations infection of AVG	8.3% 1/12 • Number of events 1 • 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.
Infections and infestations abscess, tooth	8.3% 1/12 • Number of events 1 • 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.

Other adverse events

Measure	VIG Continued Access n=12 participants at risk 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.
General disorders pain	8.3% 1/12 • Number of events 1 • 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.
Infections and infestations COVID-19	8.3% 1/12 • Number of events 1 • 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.
General disorders inflammation	8.3% 1/12 • Number of events 1 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) cancer, skin	8.3% 1/12 • Number of events 1 • 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.
General disorders bruising following a fall	8.3% 1/12 • Number of events 1 • 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.
General disorders bleeding, minor	8.3% 1/12 • Number of events 1 • 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.

Additional Information

Cindy Setum, PhD

Phraxis, Inc.

Phone: 16128016730

Email: csetum@phraxis.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER