RECRUITING

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

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Conditions

End Stage Renal Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Postmarket Surveillance, Prospective, Multicenter, Randomized, Controlled Study Evaluating the Performance of VasQ for Its Intended Use.

Quick Facts

Study Start:2025-01-13
Study Completion:2028-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06516653

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Male and non-pregnant female participants.
  3. 3. Age 18-80 years
  4. 4. Patients willing and able (physically and geographically) to attend follow up visits over a period of 12 months.
  1. 1. Index procedure being a revision surgery of an existing fistula.
  2. 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. 3. Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ.
  4. 4. Known central venous stenosis or obstruction on the side of surgery.
  5. 5. Pre-existing stents or stent grafts in the access circuit.
  6. 6. Planned subsequent fistula superficialization procedure.
  7. 7. Known coagulation disorder.
  8. 8. Known allergy to nitinol.
  9. 9. Expected kidney transplant within 12 months of enrollment.
  10. 10. Inability to give consent and/or comply with the study follow up schedule.
  11. 11. Insufficient or borderline life expectancy to allow for completion of study procedures and follow-up (12 Months).
  12. 12. Participation in another interventional study that in the judgment of the investigator could confound study results.

Contacts and Locations

Study Contact

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

Principal Investigator

John F Lucas III, MD, FACS, FSVS
PRINCIPAL_INVESTIGATOR
Greenwood Leflore Hospital

Study Locations (Sites)

Greenwood Leflore Hospital
Greenwood, Mississippi, 38930
United States

Collaborators and Investigators

Sponsor: Laminate Medical Technologies

  • John F Lucas III, MD, FACS, FSVS, PRINCIPAL_INVESTIGATOR, Greenwood Leflore Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-13
Study Completion Date2028-05

Study Record Updates

Study Start Date2025-01-13
Study Completion Date2028-05

Terms related to this study

Additional Relevant MeSH Terms

  • End Stage Renal Disease