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NCT03373695

A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary In-stent Restenosis

Completed NA Last updated 20 February 2025
What this trial tests

NA trial testing Dissolve™ in Coronary In-stent Restenosis in 260 participants. Completed in 24 April 2024.

Timeline
22 February 2018
Primary endpoint
9 January 2020
24 April 2024

Quick facts

Lead sponsorDK Medical Technology (Suzhou) Co., Ltd.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment260
Start date22 February 2018
Primary completion9 January 2020
Estimated completion24 April 2024
Sites15 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

DK Medical Technology (Suzhou) Co., Ltd.

Who can join

18 and older, any sex, with Coronary In-stent Restenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the efficacy and safety of treatment of coronary in-stent restenosis by Paclitaxel-eluting balloon catheter Dissolve™ versus SeQuent®Please, and the reference diameter of coronary artery stenosis is 2.5mm-4.0mm and the length ≤ 26mm.

Publications & conference data

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

  1. A Randomized Comparison of 2 Different Drug-Coated Balloons for In-Stent Restenosis.
    Liu S, Zhou Y, Shen Z, Chen H, et al · · 2023 · cited 11× · PMID 37045496 · DOI 10.1016/j.jcin.2022.12.018

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Other DK Medical Technology (Suzhou) Co., Ltd. trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03373695.

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