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Safety and Efficacy of Spinous Balloon Dilatation Catheter in CAD Treatment

NCT05342961 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2022-04-25

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and effectiveness of spinous process balloon dilation catheter (Plastic-Blade) in coronary vascular diseases, which is not inferior to the similar product on the market - coronary spinous process balloon dilation catheter (lacrosse NSE) produced by Goodman Co., Ltd..

Conditions

Interventions

PROCEDURE

spinous balloon dilatation catheter (Plastic-Blade)

To treat Coronary artery disease

PROCEDURE

spinous balloon dilatation catheter(lacrosse NSE)

To treat Coronary artery disease

Sponsors & Collaborators

  • Shanghai 10th People's Hospital

    collaborator OTHER

  • CCRF Inc., Beijing, China

    lead INDUSTRY

Principal Investigators

  • Yawei Xu, MD.,Ph D. · Department of Cardiology, Shanghai Tenth People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-05-16
Primary Completion
2022-12-31
Completion
2022-12-31

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Diseases

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 NCT05342961 on ClinicalTrials.gov