The journal of vascular access · 2026
Protocol of the Dragon study: Drug-coated balloon compared with cutting balloon in treatment of arteriovenous fistula stenosis.
Протокол клинического исследованияСравнительное исследованиеСтатьяНазвание и аннотация: Перевод в очереди
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Cao Ruzhou, Ni Qihong, Wang Pei, Ye Hong, Zhao Yiping, Chen Jiaquan, Li Yinan, Zhang Lan
Аннотация
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.
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.
Предметные рубрики MeSH
FemaleHumansMaleMiddle AgedAngioplasty, BalloonArteriovenous Shunt, SurgicalCardiovascular AgentsChinaCoated Materials, BiocompatibleEquipment DesignGraft Occlusion, VascularProspective StudiesRenal DialysisResearch DesignRisk FactorsTime FactorsTreatment OutcomeVascular Access DevicesVascular PatencyMulticenter Studies as TopicObservational Studies as Topic