Recruiting

Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula

Laminate Medical Technologies · NCT06516653

View Study & Apply

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation: Not posted. Ask the study team before screening.
Who can join: Ages 18–80 · All sexes
Healthy volunteers: Not accepted (a condition is required)
Study type: Interventional · Not applicable
Target enrollment: 300
US sites recruiting: 8
Study start: January 13, 2025
Record last updated: July 14, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: VasQ; Arteriovenous fistula creation for dialysis vascular access

Conditions: End Stage Renal Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

Fresenius Vascular Care Long Beach
Long Beach, CA 90706
Site contact: Deann Helton · 562-888-8961 · Deann.Helton@azuracare.com
Sarasota Memorial Hospital
Sarasota, FL 34239
Site contact: Kaitlyn Meek, RN · 941-917-7109 · kaitlyn-meek@smh.com
Grady Memorial Hospital
Atlanta, GA 30303
Site contact: Ronnie Adams · +1-404-251-8984 · rwadam2@emory.edu
Brigham and Women's Hospital
Boston, MA 02115
Site contact: Danielle Montano · 617-525-8555 · dmontano2@bwh.harvard.edu
Greenwood Leflore Hospital
Greenwood, MS 38930
Site contact: Kimberly McMillian · 662-453-4641 · kmcmillian@glh.org
Fresenius Vascular Care Columbia
Columbia, SC 29203
Site contact: Alicia Phillips-Pough · 803-252-3373 · alicia.phillips-pough@azuracare.com
Houston Methodist Hospital
Houston, TX 77030
Site contact: Abhiraj Sinha · +1-404-251-8984 · asinha@houstonmethodist.org
Fairlawn Surgery Center
Roanoke, VA 24014
Site contact: Aleisha Umber, RN · 540-904-6170 · AUMBER@FSCMED.COM

Study contacts (from the official record)

Galit Itzhaki · +972-3-6344246 · galit@laminatemedical.com