External support implant for arteriovenous fistula in dialysis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the VasQ device, an external support implant designed to enhance the creation of arteriovenous fistulas (AVF) for dialysis access in patients with end-stage renal disease. It is a postmarket, multi-center, randomized, controlled trial involving 300 participants who will be divided into two groups: one receiving the VasQ-supported fistula and the other receiving standard care. The primary endpoint is to assess the time to achieving a clinically functional AVF at six months post-procedure, with follow-up extending to twelve months. The study aims to determine the effectiveness of the VasQ device compared to conventional methods.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fresenius Vascular Care Long Beach
  Long Beach, California, United States Recruiting
• Sarasota Memorial Health Care System
  Sarasota, Florida, United States Recruiting
• Grady Memorial Hospital
  Atlanta, Georgia, United States Recruiting
• Atlanta VA Medical Center
  Decatur, Georgia, United States Recruiting
• Ochsner Clinic Foundation
  New Orleans, Louisiana, United States Recruiting
• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: John F Lucas III, MD FACS FSVS — Greenwood Leflore Hospital
• Study coordinator: Galit Itzhaki
• Email: galit@laminatemedical.com
• Phone: +972-3-6344246

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ribupatide PK in People with Kidney Impairment

  This study tests how a single shot of ribupatide behaves in the body for people with severe kidney problems compared to those with normal kidney function.

  Recruiting at 2 sites Phase 1 Kailera · Orlando, Florida and 1 other locations · NCT07793929

• Intradiay dialysis exercise to improve posture in adults with end-stage kidney disease

  This study tests whether a 12-week supervised exercise program done during dialysis can improve posture in adults on maintenance hemodialysis.

  Recruiting Pardis Specialized Wellness Institute · Isfahan · NCT07720401

• Pumpkin seed oil for people on hemodialysis

  This study tests whether taking pumpkin seed oil daily for 3 months helps reduce inflammation and improve-related lab markers in people with end-stage kidney disease on dialysis.

  Recruiting Al-Mustansiriyah University · Baghdad, Karkh · NCT07710183

• Porcine thymokidney transplant for end-stage renal disease

  This study tests whether a GalKO porcine thymokidney transplant can keep kidney function without dialysis in adults with end-stage kidney disease who are unlikely to get a standard donor kidney soon.

  Recruiting Phase 1 Xeno Holdings (US), LLC dba ChoironeX · New York, New York and 1 other locations · NCT07696962

• How inflammatory diseases change the way your body handles medicines.

  This study will see if inflammatory conditions like type 2 diabetes, IBD, or end-stage kidney disease change how common medicines are processed and increase the chance of side effects.

  Recruiting Indiana University · Indianapolis, Indiana · NCT07360938

• CRISPR-edited donor kidney transplant to reduce rejection risk

  This trial will see if donor kidneys edited with CRISPR to turn off key HLA genes can lower rejection in adults with end-stage kidney disease receiving transplants.

  Recruiting Phase 1/2 American Organ Transplant and Cancer Research Institute LLC · Beijing, Changping · NCT07053462

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.