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NCT07873736
SoniCrackerTM Single-use Intracoronary Shockwave Catheter
Conditions: Primary Coronary Artery Calcification
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 390
Sponsor: Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
Summary
This study aims to observe the safety and effectiveness of the SoniCrackerTM single-use intracoronary shockwave catheter in the pretreatment and balloon dilation of primary coronary artery calcification lesions (coronary artery stenosis ≥50%) prior to stent implantation surgery in real-world patients.
Eligibility Criteria
Inclusion Criteria:
1. Patients aged 18 and above;
2. Patients with primary coronary artery calcification (coronary artery stenosis ≥50%) who are scheduled for stent implantation and deemed suitable for pretreatment with intracoronary shockwave therapy system and balloon dilation by the investigator before stent implantation;
3. Patients who can understand the purpose of the trial, voluntarily participate, and sign the informed consent form.
Exclusion Criteria:
1. Patients with other diseases (severe congestive heart failure and severe valvular disease, malignant tumors, organ transplant recipients or candidates) or a history of abuse (alcohol, cocaine, heroin, etc.);
2. Patients who are pregnant or breastfeeding;
3. Patients who are allergic to contrast media and cannot tolerate medications such as aspirin, clopidogrel, ticagrelor, and heparin;
4. Researchers determined patients who could not tolerate the use of disposable intracoronary shockwave catheter through the lesion by angiography;
5. Patients who were deemed unsuitable for participation in the study by researchers due to other reasons.
Source: ClinicalTrials.gov (NCT07873736). StuddyBuddy aggregates publicly available trial information.