Chronic Kidney Disease Trial, Recruiting NCT06001827 Sponsor: VenoStent Condition: Chronic Kidney Disease
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Chronic Kidney Disease Trial, Recruiting

NCT06001827
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are 18 years of age or older
  • People who have been referred to have a new arteriovenous fistula (AVF) — a surgically created connection between an artery and vein, often used for dialysis access — created for the first time
  • People who are willing and able to follow the study requirements, stay in contact with the study team, and attend check-up visits over 36 months

Who may not be able to join:

  • People whose planned surgery is to fix or update an existing fistula, rather than create a new one
  • People whose target artery measures less than 2.0 mm across on the inside, as measured by ultrasound during the procedure preparation
  • People whose target vein measures less than 2.0 mm across on the inside, as measured by ultrasound during the procedure preparation
  • People who have a significant narrowing (50% or more) in the target vein on the side where surgery is planned, as found by ultrasound before the operation
  • People with a known significant narrowing (50% or more) in the large veins near the centre of the chest, on the side of the planned surgery
  • People who have a mesh tube (stent) or covered mesh tube already placed within the area where the fistula would be created
  • People with a known or suspected blood clotting disorder that the study doctor believes would make fistula surgery too risky
  • People with a known or suspected active infection at the time of surgery
  • People with severe heart failure classified at the highest level of severity (confirm with trial site)
  • People who have previously experienced a condition where the fistula caused reduced blood flow to the hand or arm on the same side as the planned surgery
  • People currently enrolled in another clinical study involving an experimental drug, device, or biological treatment, or who were previously enrolled in this same study
  • People with a life expectancy of less than 12 months
  • People expected to have a kidney transplant within 6 months of joining the study
  • People expected to do dialysis at home
  • Women who could become pregnant (i.e., who have not gone through menopause and have not had sterilisation surgery) without a documented negative pregnancy test at the screening stage
  • People with another health condition that the study doctor believes would make it difficult to collect reliable and safe study data
  • People who are unwilling or unable to give consent or follow the study visit schedule
  • People with any health condition that, in the study doctor's opinion, could affect their safety or their ability to take part in the study

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 7 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Timothy Boire, PhD, VenoStent, Inc.

Phone: (832) 429-5362

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
VenoStent
Registry
ClinicalTrials.gov
Start date
3 January 2024
Est. completion
1 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Unassisted Maturation by 180 days; Freedom from access-related adverse events through 30 days

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 7 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov