SONICURE（SONICracker for the Treatment of UndeRExpansion）

Evaluate the Safety and Effectiveness of the Intravascular Shock Wave Treatment Device and the Disposable Coronary Intravascular Shock Wave Catheter Compared With the Non-compliant Balloon Catheter in the Treatment of In-stent Restenosis of the Coronary Artery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Intravascular Shockwave Therapy Device / Disposable Coronary Shockwave Catheter; Device: Non - compliant balloon dilatation catheter

Detailed Description

In the first phase, it will be carried out at Beijing Luhe Hospital, Capital Medical University. A total of 10 subjects are planned to be enrolled. After the subjects are included in the study, they will be treated with the intravascular shock wave treatment device and the disposable coronary intravascular shock wave catheter produced by Shanghai Lifan Boyuan Medical Technology Co., Ltd. Clinical follow-ups will be conducted before discharge and one month after the operation.

In the second phase, it will be carried out at multiple clinical trial institutions in China. A total of 200 subjects are planned to be enrolled. After randomization, all subjects will undergo surgical treatment using either the investigational device or the control device. Clinical follow - up will be conducted before discharge, 1 month after surgery, and 6 months after surgery.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yang Wang; Phone Number: 13366024088; Email: yang.wang@jwmsgrp.com
• Study Contact Backup: Name: Yuanchun Sun; Phone Number: 13683382436

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Beijing Luhe Hospital Affiliated to Capital Medical University
      • Contact: Guangyao Zhai; Phone Number: 010-69543901-1081; Email: ml.zuo@jwmsgrp.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged between 18 and 80 years old, either male or non - pregnant female.
• Suffering from heart diseases with clinical evidence of ischemia, such as Chronic Coronary Syndrome (CCS) or Acute Coronary Syndrome (ACS).
• The subject should be able to understand the purpose of the trial, voluntarily participate in it, and sign the informed consent form.
• During the baseline surgery, at most one target lesion can be treated.
• The target lesion and non - target lesion are not located in the same blood vessel.
• The reference vessel diameter of the target lesion is 2.25 - 4.0 mm (estimated visually).

Exclusion Criteria:

• Patients who have had any myocardial infarction within 1 week, or patients who have had a myocardial infarction more than 1 week ago but whose myocardial enzymes CK or CK-MB have not yet returned to normal.
• Patients with New York Heart Association (NYHA) class III or IV heart failure or those with severe valvular heart disease.
• Female patients who are planning to become pregnant (or are breastfeeding).
• Severe impairment of liver and kidney function, with transaminase levels more than 3 times the upper limit of the normal value, serum creatinine > 2.5 mg/dL (221 μmol/L), or chronic renal failure requiring long-term dialysis.
• Severe hypertension that cannot be controlled despite treatment (systolic blood pressure persistently > 180 mmHg or diastolic blood pressure persistently > 110 mmHg).
• Coagulation disorders, with a platelet count < 100×10⁹/L.
• Patients with cardiogenic shock.
• Patients who need to receive cytostatic agents or radiotherapy due to accompanying diseases.
• Patients known to be allergic to heparin, contrast agents, aspirin, clopidogrel, or anesthetics.
• Patients with a bleeding diathesis, or those with a history of cerebral hemorrhage, active peptic ulcer, or gastrointestinal bleeding within the past 6 months, for whom anticoagulant therapy or the use of anticoagulant drugs will be restricted or prohibited.
• Patients with a life expectancy of less than 6 months or those with potential factors that may cause difficulties in clinical follow-up.
• Patients who are currently participating in any other clinical trial. Patients who, for other reasons, are considered by the investigator to be unsuitable for inclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intravascular Shockwave Therapy Device / Disposable Coronary Shockwave Catheter; Intravascular Shockwave Therapy Device / Disposable Coronary Shockwave Catheter (Shanghai Lanfan Boyuan Medical Technology Co., Ltd.)	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.
Active Comparator: non-compliant balloon dilatation catheter; Randomized to the control group using a non-compliant balloon dilatation catheter (Shandong Jiwei Medical Products Co., Ltd.) to treat the lesion	Device: Non - compliant balloon dilatation catheter; Randomly assign subjects to the control group to treat the lesions with a non - compliant balloon catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical success rate	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).	during the hospitalization period (up to 7 days after the operation).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device success rate	Security endpoint	Immediately after the operation
The minimum stent area immediately after the operation（MSA）	Measured by Optical Coherence Tomography (OCT)	Immediately after the operation
The minimum stent lumen diameter immediately after the operation（MLD）	Measured by Optical Coherence Tomography (OCT)	Immediately after the operation
The incidence of Major Adverse Cardiovascular Events (MACE)	Safety endpoint	before discharge, one month after the operation
The incidence of target lesion failure (TLF)	Safety endpoint	one month after the operation
The incidence of serious adverse events	Safety endpoint	before discharge, one month after the operation
The incidence of device defects	Safety endpoint	during the operation
The incidence of serious angiographic complications	Safety endpoint	during the operation

Collaborators and Investigators

• Sponsor: Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
• Investigators: Principal Investigator: Guangyao Zhai, Beijing Luhe Hospital Affiliated to Capital Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 17, 2025
• First Submitted That Met QC Criteria: April 6, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 6, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: SONICURE
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: LFBY-202503

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No