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Efficacy and Safety of Intravascular High-pressure Cutting Balloon Catheters for PCI

NCT06214754 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2025-06-06

No results posted yet for this study

Summary

The purpose of this study was to evaluate the safety and efficacy of intravascular high-pressure cut balloon catheter compared to cut balloon catheter during PCI, and to support product registration and clinical application.

Conditions

  • Atherosclerotic Plaque

Interventions

PROCEDURE

PCI

The subjects underwent immediate coronary angiography after Percutaneous transluminal coronary angioplasty to evaluate the success rate of instruments, and immediate coronary angiography after PCI to evaluate the success rate of clinical treatment

Sponsors & Collaborators

  • BrosMed Medical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-06-16
Primary Completion
2023-08-22
Completion
2023-12-28

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 NCT06214754 on ClinicalTrials.gov