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New treatment option for End Stage Renal Disease
Official title Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
ClinicalTrials.gov ID: NCT06516653
What this study is testing
- What it's testing
- 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
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Patients who are candidates for the creation of a new radiocephalic or brachiocephalic end-to-side surgical AV fistula for dialysis access (per VasQ...
- 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.
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- 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.
- 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 treatment study that in the judgment of the investigator could confound study results.
The study team makes the final eligibility decision.
Where it's taking place
- Long Beach, California, United States
- Sarasota, Florida, United States
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- Greenwood, Mississippi, United States
- Las Vegas, Nevada, United States
- Columbia, South Carolina, United States
- Houston, Texas, United States
- Roanoke, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Long Beach, California, United States; Sarasota, Florida, United States; Atlanta, Georgia, United States; Boston, Massachusetts, United States; Greenwood, Mississippi, United States; Las Vegas, Nevada, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.