SONICURE(SONICracker for the Treatment of UndeRExpansion)
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Non - compliant balloon dilatation catheter: Randomly assign subjects to the control group to treat the lesions with a non - compliant balloon catheter.
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.
Eligibility
Primary outcome measure(s)
- Surgical success rate — during the hospitalization period (up to 7 days after the operation).
The residual stenosis after the operation is ≤ 30%, and there is no occurrence of Major Adverse Cardiac Events (MACE) during the hospitalization period (up to 7 days after the operation).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing Luhe Hospital Affiliated to Capital Medical University | Beijing | Beijing Municipality |
More Shanghai Bluesail Boyuan Medical Technology Co., Ltd. trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06924736 on ClinicalTrials.gov ↗ ← All trials in China