NCT06924736Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 11 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 17 Mar 2025
- Start date
- 15 May 2025
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
- Diseases
- Coronary artery disease
- NCT number
- NCT06924736
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 15 May 2025 to the primary completion date, 1 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- Severe hypertension that cannot be controlled despite treatment (systolic blood pressure persistently \> 180 mmHg or diastolic blood pressure persistently \> 110 mmHg).
- 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.
Lab values
- 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.
- Coagulation disorders, with a platelet count \< 100×10⁹/L.
Other
- Female patients who are planning to become pregnant (or are breastfeeding).
- Patients with cardiogenic shock.
- 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.
Who the study is looking for
- 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).
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Luhe Hospital affiliated to Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.