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

NCT03373695 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2025-02-20

No results posted yet for this study

Summary

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.

Conditions

  • Coronary In-stent Restenosis

Interventions

DEVICE

Dissolve™

Dissolve™ are to be used in the trial

DEVICE

SeQuent®Please

SeQuent®Please are to be used in the trial

Sponsors & Collaborators

  • Core Medical (Beijing) Co., Ltd.

    collaborator OTHER

  • DK Medical Technology (Suzhou) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Shubin Qiao · Chinese Academy of Medical Sciences, Fuwai Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-22
Primary Completion
2020-01-09
Completion
2024-04-24

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03373695 on ClinicalTrials.gov