SONICURE（SONICracker for the Treatment of UndeRExpansion）

NCT06924736 | Not Yet Recruiting DMC

• 1 other identifier: LFBY-202503
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

SONICURE

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Device success rate

  Immediately after the operation

• The minimum stent area immediately after the operation（MSA）

  Immediately after the operation

• The minimum stent lumen diameter immediately after the operation（MLD）

  Immediately after the operation

• The incidence of Major Adverse Cardiovascular Events (MACE)

  before discharge, one month after the operation

• The incidence of target lesion failure (TLF)

  one month after the operation

Study Arms (2)

Intravascular Shockwave Therapy Device / Disposable Coronary Shockwave Catheter

EXPERIMENTAL

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

Device: Intravascular Shockwave Therapy Device / Disposable Coronary Shockwave Catheter

non-compliant balloon dilatation catheter

ACTIVE COMPARATOR

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

Interventions

Intravascular Shockwave Therapy Device / Disposable Coronary Shockwave Catheter DEVICE

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

Intravascular Shockwave Therapy Device / Disposable Coronary Shockwave Catheter

Non - compliant balloon dilatation catheter DEVICE

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

non-compliant balloon dilatation catheter

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Bluesail Boyuan Medical Technology Co., Ltd.: lead

Study Sites (1)

Beijing Luhe Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Guangyao Zhai

  Beijing Luhe Hospital Affiliated to Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Wang

CONTACT

13366024088; yang.wang@jwmsgrp.com

Yuanchun Sun

CONTACT

13683382436

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 11, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)