Diabetes Mellitus Clinical Trial
Official title:
A Multi-center Prospective Study to Evaluate the Safety and Effectiveness of the VasQ External Support for Arteriovenous Fistula
NCT number | NCT03242343 |
Other study ID # | CD0121 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 29, 2017 |
Est. completion date | April 3, 2022 |
Verified date | October 2023 |
Source | Laminate Medical Technologies |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 144 |
Est. completion date | April 3, 2022 |
Est. primary completion date | October 8, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Albany Medical College | Albany | New York |
United States | University of Michigan | Ann Arbor | Michigan |
United States | Cardiothoracic and Vascular Surgeons, P.A. | Austin | Texas |
United States | Grandview Medical Center | Birmingham | Alabama |
United States | Boston Medical Center | Boston | Massachusetts |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Charlotte PA | Charlotte | North Carolina |
United States | Ohio State University Wexner Meidcal Center | Columbus | Ohio |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Lutheran Medical Group/Indiana Ohio Heart | Fort Wayne | Indiana |
United States | Greenville Health System | Greenville | South Carolina |
United States | Methodist DeBakey Heart and Vascular Center,The Methodist Hospital | Houston | Texas |
United States | Montefiore Medical Center | New York | New York |
United States | Saint Francis Medical Center | Peoria | Illinois |
United States | Arizona Kidney Disease & Hypertension Center | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Laminate Medical Technologies |
United States,
Chemla E, Velazquez CC, D'Abate F, Ramachandran V, Maytham G. Arteriovenous fistula construction with the VasQ external support device: a pilot study. J Vasc Access. 2016 May 7;17(3):243-8. doi: 10.5301/jva.5000527. Epub 2016 Apr 14. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary Patency of AVF | Proportion of patients with freedom from intervention since device placement | 6 months post AVF creation | |
Primary | Occurrence of safety events | The occurrence per patient access related safety events | Device implantation to 6 months post AVF creation |
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