An observational study in Primary Coronary Artery Calcification, sponsored by Shanghai Bluesail Boyuan Medical Technology Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Shanghai Bluesail Boyuan Medical Technology Co., Ltd. (part of Blue Sail Medical Co., Ltd.) · Observational
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.
Shanghai Bluesail Boyuan Medical Technology Co., Ltd. is the lead sponsor of 7 studies on the registry; 7 are open to participants now.
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It is used for pre-treatment and balloon dilation of primary coronary artery calcification lesions (coronary artery stenosis ≥50%) in adult patients before stent implantation surgery.
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Exclusion Criteria:
Surgical success rate
Time frame: After successful stent implantation, the residual stenosis within the stent is ≤30%, and there is no major adverse cardiovascular event (MACE) during hospitalization (up to 7 days after surgery).
Device success rate:
The disposable intracoronary shockwave catheter successfully passed through the target lesion, dilated, completed shockwave pretreatment, and successfully decompressed and withdrew after treatment, with no immediate severe angiographic complications.
Time frame: After successful stent implantation, the residual stenosis within the stent is ≤30%, and there is no major adverse cardiovascular event (MACE) during hospitalization (up to 7 days after surgery).
The incidence of MACE during hospitalization (up to 7 days post-surgery)
MACE includes: cardiac death, myocardial infarction, and target vessel revascularization \[TVR\]
Time frame: After successful stent implantation, the residual stenosis within the stent is ≤30%, and there is no major adverse cardiovascular event (MACE) during hospitalization (up to 7 days after surgery).
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Shanghai Bluesail Boyuan Medical Technology Co., Ltd. →