BridgeMD
Compares treatment options for Arteriovenous Shunt Thrombosis
Official title Sirolimus Drug-coated Balloon Versus Stent Graft
ClinicalTrials.gov ID: NCT05938530
What this study is testing
- What it's testing
- A functioning dialysis vascular access is critical to the delivery of lifesaving hemodialysis. Arteriovenous graft (AVG) is a surgically created vascular access used for hemodialysis in patients with end-stage renal disease.
- 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 21 to 85
You may be able to join if
- Thrombosed AVG in the upper arm
- Successful thrombolysis of the thrombosed AVG, defined as the re-established of flow on Digital Subtraction Angiography (DSA) and restoration of...
You likely can't join if
- Patient unable to provide informed consent
- Previous bare metal stent or stent-graft placement within the dialysis access
- Previous treatment with DCB within 3 months
- Presence of central vein stenosis which cannot be adequately treated (residual recoil of more than 30%)
- Failure to re-establish blood flow
- Failure to adequately treat the GV junction (defined as residual stenosis of more than 30%)
See the full eligibility criteria
- Thrombosed AVG in the upper arm
- Successful thrombolysis of the thrombosed AVG, defined as the re-established of flow on Digital Subtraction Angiography (DSA) and restoration of thrill in the AVG on clinical examination (to be determined during...
- Patient unable to provide informed consent
- Previous bare metal stent or stent-graft placement within the dialysis access
- Previous treatment with DCB within 3 months
- Presence of central vein stenosis which cannot be adequately treated (residual recoil of more than 30%)
- Failure to re-establish blood flow
- Failure to adequately treat the GV junction (defined as residual stenosis of more than 30%)
- Sepsis or active infection
- Recent intracranial bleed or gastrointestinal bleed within the past 12 months
- Allergy to iodinated contrast media, anti-platelet drugs, heparin or sirolimus
- Pregnancy
- Life expectancy \< 12 months based on physician's estimate (eg. active malignancy)
The study team makes the final eligibility decision.
Where it's taking place
- Singapore, Singapore
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 21 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore, Singapore. 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.