NCT06516653 · Laminate Medical Technologies
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
What this study is about
VasQ is an external support implant for arteriovenous fistulas created for dialysis access. This is a postmarket surveillance, forward-looking, multi-center, randomly assigned, controlled, open label trial enrolling 300 patients randomly assigned into two study treatment group$1: * Treatment treatment group$1: End to side fistula supported with VasQ * Control: the usual treatment end to side fistula
View original scientific description
VasQ is an external support implant for arteriovenous fistulas created for dialysis access.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients who are candidates for the creation of a new radiocephalic or brachiocephalic end-to-side surgical AV fistula for dialysis access (per VasQ IFU and investigator clinical judgment) and consent to take part in the study.
- Male and non-pregnant female participants.
- Age 18-80 years
- Patients willing and able (physically and geographically) to attend follow up visits over a period of 12 months.
Exclusion criteria
- Index procedure being a revision surgery of an existing fistula.
- Significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on preoperative ultrasound. (Scan should include the full length of the expected fistula outflow, starting at the planned anastomosis site)
- Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ.
- Known central venous stenosis or obstruction on the side of surgery.
- Pre-existing stents or stent grafts in the access circuit.
- Planned subsequent fistula superficialization procedure.
- Known coagulation disorder.
- Known allergy to nitinol.
- Expected kidney transplant within 12 months of enrollment.
- Inability to give consent and/or comply with the study follow up schedule.
- Insufficient or borderline life expectancy to allow for completion of study procedures and follow-up (12 Months).
- Participation in another interventional study that in the judgment of the investigator could confound study results.
Where
- Long Beach, California
- Sarasota, Florida
- Boston, Massachusetts
- Greenwood, Mississippi
- Las Vegas, Nevada
- Columbia, South Carolina
- Roanoke, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 30, 2025 · Source of record for eligibility and locations