Aneurysm, Arterio-Venous Fistula, Diabetes Mellitus, ESRD, Kidney Failure, Renal Disease, Renal Failure, Steal Syndrome
Conditions
Brief summary
This is a prospective clinical study of the VasQ external support for arteriovenous fistulas. The device is designed to improve fistula outcomes by optimizing the geometrical configuration of the fistula, influencing hemodynamics, minimizing turbulence and promote laminar flow. All patients will be implanted with the VasQ device and will be followed up for a duration of 24 months.
Interventions
DEVICEVasQ
An external support device for AV fistula
Sponsors
Laminate Medical Technologies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Main study cohort: Patients referred for creation of a new brachiocephalic fistula who consent to take part in the study and which are not indicated for a more distal fistula per treatment guidelines. Supplementary study cohort: Patients referred for creation of a new forearm fistula who consent to take part in the study. 2. Male and female participants. 3. Age 18-80 years. 4. Patients willing and able to attend follow up visits over a period of 24 months.
Exclusion criteria
1. Patients with the planned index procedure being a revision surgery of an existing fistula. 2. Main study cohort: Target artery smaller than 2.5 mm or larger than 6 mm in inner diameter by preoperative ultrasound. Supplementary study cohort: Target artery smaller than 2 mm or larger than 4.1 mm in inner diameter by preoperative ultrasound. 3. Main study cohort: Target vein smaller than 2.5 mm in inner diameter by preoperative ultrasound. Supplementary study cohort: Target vein smaller than 2 mm in inner diameter by preoperative ultrasound. 4. Significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on preoperative ultrasound. (Scan should include the area between the planned anastomosis site and the Axillary vein.) 5. Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ. 6. Patients with central venous stenosis or obstruction on the side of surgery. 7. Depth of vein greater than 8 mm (on ultrasound) on side of surgery. 8. Known coagulation disorder. 9. Congestive heart failure NYHA class ≥ 3. 10. Prior steal on the side of surgery. 11. Known allergy to nitinol. 12. Life expectancy less than 30 months. 13. Patients expecting to undergo kidney transplant within 6 months of enrollment. 14. Women of child bearing age without documented current negative pregnancy test. 15. Inability to give consent and/or comply with the study follow up schedule.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Patency of AVF | 6 months post AVF creation | Proportion of patients with freedom from intervention since device placement |
| Number of Participants With Access Related Safety Events | Device implantation to 6 months post AVF creation | Number of participants with access related steal syndrome, AVF infection, AVF aneurysm, or seroma |
Countries
United States
Contacts
STUDY_DIRECTORNoam Zilberman
Laminate Medical Technologies Ltd.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 58.9 years STANDARD_DEVIATION 11.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 122 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 51 Participants |
| Race (NIH/OMB) More than one race | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 77 Participants |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 21 / 144 |
| other Total, other adverse events | 0 / 144 |
| serious Total, serious adverse events | 9 / 144 |
Outcome results
None listed