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Not Yet Recruiting 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07873736). StuddyBuddy aggregates publicly available trial information.