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A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary Small Vessel Disease

NCT03376646 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 277

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 in the treatment of Coronary Small Vessel Disease by drug coated balloon (DCB) Dissolve™ versus drug eluting stent (DES) Resolute™ Integrity.

Conditions

  • Coronary Small Vessel Disease

Interventions

DEVICE

Cohort A: Dissolve™

Dissolve™ are to be used in the trial

DEVICE

Cohort A: Resolute™ Integrity

Resolute™ Integrity are to be used in the trial

DEVICE

Cohort B: Dissolve™-2.00mm

Dissolve™ 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
2018-06-20
Primary Completion
2020-01-10
Completion
2024-04-15

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 NCT03376646 on ClinicalTrials.gov