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Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease

NCT05509296 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2026-03-27

Study results available
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Summary

The objective of this study is to evaluate safety and effectiveness of the SINOMED CBC coronary dilatation catheter during PCI in subjects with stenotic coronary arteries.

Conditions

  • Coronary Stenosis
  • Coronary Artery Stenosis
  • In-stent Restenosis

Interventions

DEVICE

SINOMED CBC

The Coronary Dilatation Balloon Catheter is indicated for the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for the purpose of improving myocardial perfusion.

DEVICE

NSE Coronary Dilatation Catheter

The Coronary Dilatation Balloon Catheter is indicated for the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for the purpose of improving myocardial perfusion.

Sponsors & Collaborators

  • Peking University First Hospital

    collaborator OTHER

  • Sino Medical Sciences Technology Inc.

    lead INDUSTRY

Principal Investigators

  • jianping li, M.D/Ph.D · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-20
Primary Completion
2022-11-23
Completion
2022-11-23

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 NCT05509296 on ClinicalTrials.gov