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SONICURE（SONICracker for the Treatment of UndeRExpansion）

NCT06924736 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-04-11

No results posted yet for this study

Summary

The first-phase study is a prospective, single-group observational study. It plans to recruit patients with in-stent restenosis caused by poor stent expansion in the coronary artery. The intravascular shock wave treatment device and the disposable coronary intravascular shock wave catheter produced by Shanghai Lifan Boyuan Medical Technology Co., Ltd. will be used for treatment. This is a clinical trial to verify the feasibility, preliminary safety and effectiveness of treating in-stent restenosis caused by poor stent expansion in the coronary artery.

The second-phase study is a prospective, multicenter, randomized controlled clinical trial is planned to recruit patients with in - stent restenosis caused by poor coronary stent expansion. These patients will be treated with either the intravascular shock wave treatment device and the disposable coronary intravascular shock wave catheter produced by Shanghai Lifan Boyuan Medical Technology Co., Ltd., or a non - compliant balloon dilation catheter (Shandong JW Medical Products Co., Ltd., National Medical Device Registration No. 20213031019). The purpose is to verify the safety and effectiveness of the investigational medical devices in treating in - stent restenosis caused by poor coronary stent expansion.

Conditions

Interventions

DEVICE

Intravascular Shockwave Therapy Device / Disposable Coronary Shockwave Catheter

Randomly assign subjects to the experimental group to treat the lesions with an intravascular shockwave therapy device/disposable coronary artery shockwave catheter.

DEVICE

Non - compliant balloon dilatation catheter

Randomly assign subjects to the control group to treat the lesions with a non - compliant balloon catheter.

Sponsors & Collaborators

  • Shanghai Bluesail Boyuan Medical Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Guangyao Zhai · Beijing Luhe Hospital Affiliated to Capital Medical 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
2025-05-15
Primary Completion
2026-06-01
Completion
2026-12-31

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 NCT06924736 on ClinicalTrials.gov