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Wedge NC - Scoring Balloon Dilatation Catheter

NCT06214247 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2024-01-19

No results posted yet for this study

Summary

To evaluate the efficacy and safety of Wedge NC Scoring Balloon Dilatation Catheter for dilating coronary stenosis during PCI in comparison with a similar product on the market.

Conditions

Interventions

DEVICE

Wedge NC Scoring Balloon Dilatation Catheter

During PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using the Wedge NC Scoring Balloon Dilatation Catheter in the test group, subsequently completing the remaining procedure.

DEVICE

Scoreflex Scoring Balloon Dilatation Catheter

During PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using a similar product on the market in the control group, subsequently completing the remaining procedure.

Sponsors & Collaborators

  • BrosMed Medical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Jian'an Wang · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-27
Primary Completion
2022-02-28
Completion
2022-05-17

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT06214247 on ClinicalTrials.gov