Status:
NOT_YET_RECRUITING
SONICURE（SONICracker for the Treatment of UndeRExpansion）
Lead Sponsor:
Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
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...
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 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06924736
Start Date
May 15 2025
End Date
December 31 2026
Last Update
April 11 2025
Active Locations (1)
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1
Beijing Luhe Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China