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NCT04641468

Clinical Efficacy and Safety of a Prospective, Multicenter Drug Coated Balloon for Left Main Artery Disease in China

Status unknown NA Last updated 27 November 2020
What this trial tests

NA trial testing DCB in Coronary Diseases in 30 participants. Status unknown.

Timeline
1 November 2018
Primary endpoint
31 December 2020
31 December 2021

Quick facts

Lead sponsorXuzhou Third People's Hospital
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date1 November 2018
Primary completion31 December 2020
Estimated completion31 December 2021
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Xuzhou Third People's Hospital

Who can join

Adults 18 to 75, any sex, with Coronary Diseases or Left Main Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective and observational study. Patients with primary mediana 010 or 001 left main bifurcation lesions were treated with drug ball coated balloon from November 2018 to November 2020 in four hospitals in Huaihai area. The clinical characteristics, pathological changes, operation process and perioperative drug treatment data were collected. Clinical follow-up included hospitalization, postoperative telephone or outpatient follow-up. Objective to compare the safety and efficacy of drug-eluting balloon and drug-eluting stent implantation alone in the treatment of primary mediana 010 or 001 left main bifurcation lesions.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Long-Term Clinical Outcomes After Percutaneous Coronary Intervention With Drug-Coated Balloon-Only Strategy in <i>de novo</i> Lesions of Large Coronary Arteries.
    Hu FW, Chang S, Li Q, Zhu YX, et al · · 2022 · cited 16× · PMID 35911516 · DOI 10.3389/fcvm.2022.882303

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Other trials of DCB

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Other Xuzhou Third People's Hospital trials

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