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Coronary Non-slip Balloon Catheter in Patients With Coronary Artery Stenosis(CREST)

NCT05606367 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-04-07

No results posted yet for this study

Summary

This is a prospective, multicenter, randomized controlled clinical investigation aiming to evaluate the safety and effectiveness of non-slip balloon catheter for the treatment of patients with coronary artery stenosis.

Conditions

  • Coronary Artery Stenosis

Interventions

DEVICE

Non-slip Balloon Catheter of Shanghai MicroPort Rhythm

The principle of Non-slip Balloon Catheter in dilating stenotic lesions is mechanical extrusion of the vessel through the balloon, resulting in irregular rupture of atheromatous plaque and enlargement of the lumen.

DEVICE

NSE Coronary Dilatation Catheter

The Lacrosse® NSE is an angioplasty catheter with 3 longitudinal elements attached directly proximal and distal to the balloon that produces 3 endovascular surgical incisions during balloon dilation.

Sponsors & Collaborators

  • Shanghai MicroPort Rhythm MedTech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jun Bu, M.D. · RenJi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-03
Primary Completion
2023-08-31
Completion
2023-10-31

Countries

  • China

Study Locations

More Related Trials

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 NCT05606367 on ClinicalTrials.gov