Evaluation of Safety and Effectiveness of the SONICO-CX Intracoronary Electrohydraulic Shockwave … (NCT05732025) | Clinical Trial Compass
UnknownNot Applicable
Evaluation of Safety and Effectiveness of the SONICO-CX Intracoronary Electrohydraulic Shockwave Balloon Catheter
12 participantsStarted 2023-05
Plain-language summary
Calcified coronary lesions often run through various complex lesions, which increases the difficulty of coronary intervention, is one of the main challenges faced by interventional cardiovascular physicians. Severely calcified lesions, or severely calcified lesions with twisted, angulated, diffused, significantly increase rates of immediate complications and early and late major adverse cardiovascular events. Correctly identifying and evaluating calcified lesions, and selecting the most appropriate treatment strategy according to the degree of coronary artery calcification are very important for improving the success rate of intervention, reducing complications, and improving the short-term and long-term prognosis of patients.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years old
✓. Evidence of asymptomatic ischemia, stable or unstable angina
✓. Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent, and are willing to accept angiography, OCT examination and clinical follow-up.
✓. The target lesion is primary and in situ coronary artery lesion
✓. The length of the target lesion is ≤60mm, and the diameter of the target lesion is 2.5-4.0mm (visually)
✓. The stenosis rate of the target lesion diameter is ≥70%, and the doctor judges that it is necessary to implant a stent (visual inspection method) to meet one of the following:
✓. Diameter stenosis ≥ 70%, \< 100%
✓. ≥50%, \<70% with evidence of ischemia
Exclusion criteria
✕. Acute myocardial infarction occurred within 30 days before operation
What they're measuring
1
Stent expansion rate using OCT
Timeframe: Immediately after surgery
Trial details
NCT IDNCT05732025
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University