NCT06516653 Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
| NCT ID | NCT06516653 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Laminate Medical Technologies |
| Condition | End Stage Renal Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-01-13 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2025-01-13 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
VasQ is an external support implant for arteriovenous fistulas created for dialysis access. This is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized into two study arms: * Treatment arm: End to side fistula supported with VasQ * Control: Standard of care end to side fistula
Eligibility Criteria
Inclusion Criteria: 1. 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. 2. Male and non-pregnant female participants. 3. Age 18-80 years 4. Patients willing and able (physically and geographically) to attend follow up visits over a period of 12 months. Exclusion Criteria: 1. Index procedure being a revision surgery of an existing fistula. 2. 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) 3. Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ. 4. Known central venous stenosis or obstruction on the side of surgery. 5. Pre-existing stents or stent grafts in the access circuit. 6. Planned subsequent fistula superficialization procedure. 7. Known coagulation disorder. 8. Known allergy to nitinol. 9. Expected kidney transplant within 12 months of enrollment. 10. Inability to give consent and/or comply with the study follow up schedule. 11. Insufficient or borderline life expectancy to allow for completion of study procedures and follow-up (12 Months). 12. Participation in another interventional study that in the judgment of the investigator could confound study results.
Contact & Investigator
John F Lucas III, MD FACS FSVS
PRINCIPAL INVESTIGATOR
Greenwood Leflore Hospital
Frequently Asked Questions
Who can join the NCT06516653 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying End Stage Renal Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06516653 currently recruiting?
Yes, NCT06516653 is actively recruiting participants. Contact the research team at galit@laminatemedical.com for enrollment information.
Where is the NCT06516653 trial being conducted?
This trial is being conducted at Long Beach, United States, Sarasota, United States, Atlanta, United States, Boston, United States and 5 additional locations.
Who is sponsoring the NCT06516653 clinical trial?
NCT06516653 is sponsored by Laminate Medical Technologies. The principal investigator is John F Lucas III, MD FACS FSVS at Greenwood Leflore Hospital. The trial plans to enroll 300 participants.