Comparison of Sirolimus Drug-coated Balloon and Stent Graft for Thrombosed Dialysis Access
Sirolimus Drug-coated Balloon Versus Stent Graft for Thrombosed Arteriovenous Graft (SUSTAIN)
This study is testing whether a special drug-coated balloon works as well as a stent graft in keeping blocked dialysis access open for patients with end-stage kidney disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 21 Years to 85 Years |
| Sex | All |
| Sponsor | Singapore General Hospital Academic / other |
| Locations | 1 site (Singapore) |
| Trial ID | NCT05938530 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of sirolimus drug-coated balloons versus stent grafts in maintaining the patency of thrombosed arteriovenous grafts (AVGs) after successful thrombolysis. The research focuses on patients with end-stage renal disease who experience AVG thrombosis, a common complication that can lead to hospitalization. By evaluating the primary patency rates at six months post-treatment, the study seeks to determine if the drug-coated balloon is as effective as the stent graft in preventing re-thrombosis. The approach combines advanced imaging techniques and minimally invasive interventions to improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with thrombosed AVGs in the upper arm who have successfully undergone thrombolysis.
Not a fit: Patients with central vein stenosis that cannot be adequately treated or those with a life expectancy of less than 12 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved long-term outcomes for patients requiring hemodialysis by enhancing the durability of their vascular access.
How similar studies have performed: Other studies have shown promising results with drug-coated balloons in vascular interventions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 procedure) Exclusion Criteria: * 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)
Where this trial is running
Singapore
- Singapore General Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Ru Yu Tan — Singapore General Hospital
- Study coordinator: Ru Yu Tan
- Email: tan.ru.yu@singhealth.com.sg
- Phone: +6563214436
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.