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

RecruitingNAAges 18 Years - 80 YearsAllLaminate Medical Technologies
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • VasQ
  • Arteriovenous fistula creation for dialysis vascular access
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Where

9 sites
Fresenius Vascular Care Long Beach
Long Beach, United States
Sarasota Memorial Hospital
Sarasota, United States
Grady Memorial Hospital
Atlanta, United States
Brigham and Women's Hospital
Boston, United States
Greenwood Leflore Hospital
Greenwood, United States
Azura Surgery Center Las Vegas
Las Vegas, United States
Fresenius Vascular Care Columbia
Columbia, United States
Houston Methodist Hospital
Houston, United States

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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