Protocol of the Dragon study: Drug-coated balloon compared with cutting balloon in treatment of arteriovenous fistula stenosis

Abstract

Background:

Endovascular therapy is the preferred option for arteriovenous fistula dysfunction. The aim of this trial is to compare the 12-month efficacy and safety outcomes of cutting balloon with the drug-coated balloon.

Methods and analysis:

The DRAGON study is a multicenter, prospective, observational cohort study. One hundred and eighty patients with stenosis of the venous segment of arteriovenous fistula will be recruited for treatment with the cutting balloon or the drug-coated balloon. The primary efficacy endpoint is the 12-month target-lesion primary patency rate. The secondary efficacy endpoints are the 3- and 6-month target-lesion primary patency rate, the 6- and 12-month access-circuit primary patency rate, the total number of target-lesion reintervention, the 12-month target-lesion reintervention rate, and the 12-month access-circuit thrombosis rate. The safety endpoints included complications and death.

Ethics and dissemination:

The Dragon study has been registered at www.clinicaltrials.gov (registration number: NCT06527963). The study protocol has been approved by the Institutional review board and Human Research Ethics Committee of Renji Hospital, School of Medicine, Shanghai Jiao Tong University (Approved number: LY2024-102-B). The results will be disseminated by publication in a peer-reviewed journal.