SONICURE（SONICracker for the Treatment of UndeRExpansion）

NCT ID: NCT06924736

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-15
• Study Completion Date: 2026-12-31

Brief 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.

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intravascular Shockwave Therapy Device / Disposable Coronary Shockwave Catheter

Intravascular Shockwave Therapy Device / Disposable Coronary Shockwave Catheter (Shanghai Lanfan Boyuan Medical Technology Co., Ltd.)

Group Type: EXPERIMENTAL

Intravascular Shockwave Therapy Device / Disposable Coronary Shockwave Catheter

Intervention Type: DEVICE

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

Randomized to the control group using a non-compliant balloon dilatation catheter (Shandong Jiwei Medical Products Co., Ltd.) to treat the lesion

Group Type: ACTIVE_COMPARATOR

Non - compliant balloon dilatation catheter

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Non - compliant balloon dilatation catheter

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Bluesail Boyuan Medical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guangyao Zhai

Role: PRINCIPAL_INVESTIGATOR

Beijing Luhe Hospital Affiliated to Capital Medical University

Locations

Beijing Luhe Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Yang Wang

Role: CONTACT

yang.wang@jwmsgrp.com

13366024088

Yuanchun Sun

Role: CONTACT

13683382436

Facility Contacts

Guangyao Zhai

Role: primary

ml.zuo@jwmsgrp.com

010-69543901-1081

Other Identifiers

LFBY-202503

Identifier Type: -

Identifier Source: org_study_id