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Scoreflex TRIO - Scoring PTCA Catheter

NCT05929313 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2024-08-26

No results posted yet for this study

Summary

To evaluate the acute safety and device procedural success of the Scoreflex TRIO Scoring PTCA catheters versus Scoreflex NC Scoring PTCA catheters in subjects with stenotic coronary arteries during percutaneous coronary intervention.

Conditions

  • Coronary Arteriosclerosis

Interventions

DEVICE

OrbusNeich Scoreflex TRIO

To dilate coronary arteries during the subject's index procedure with Scoreflex TRIO Scoring PTCA catheters

DEVICE

OrbusNeich Scoreflex NC

To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters

Sponsors & Collaborators

  • CCRC Medtech (Shanghai) Co., Ltd.

    collaborator UNKNOWN

  • OrbusNeich

    lead INDUSTRY

Principal Investigators

  • Jun Bo Ge, MD · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-04-27
Primary Completion
2024-04-30
Completion
2024-05-29

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 NCT05929313 on ClinicalTrials.gov