A Real-world Registry Investigating Sirolimus-coated Balloon Versus Paclitaxel-coated Balloon Angioplasty for the Treatment of Dysfunctional Arteriovenous Fistula

Charyl Yap

CONTACT

Lead Sponsor

Singapore General Hospital

Age

21 - 85 years

Sex

ALL

Healthy Volunteers

No

•Age 21-85 years
•Patient who required balloon angioplasty for dysfunctional or thrombosed AVF
•Successful thrombolysis and angioplasty of the underlying stenosis, defined as less than 30% residual stenosis on Digital Subtraction Angiography (DSA) based on visual assessment of the operator and restoration of thrill in the AVF on clinical examination. For concurrent asymptomatic or angiographically not significant central vein stenosis, patients can be included in no treatment is required.
•received either PDCB or SDCB for the treatment of stenosis.

•Patient unable to provide informed consent
•Presence of symptomatic or angiographically significant central vein stenosis who require treatment, with more than 30% residual stenosis post angioplasty
•Patients who had underwent stent placement within the AVF circuit
•Sepsis or active infection
•Recent intracranial bleed or gastrointestinal bleed within the past 12 months.
•Allergy to iodinated contrast media, heparin, paclitaxel or sirolimus
•Pregnancy
•Inadequate treatment of underlying stenosis, defined as \>= 30% residual stenosis of the underlying lesions.