This is a prospective and multicenter clinical investigation aiming to evaluate the safety and effectiveness of coronary intravascular lithotripsy system for the treatment of patients with coronary calcification.
This trial is a prospective and multicenter clinical trial. 189 subjects are expected to be recruited in 20 research centers in China. 1. All subjects with coronary calcified lesions participating in this clinical study must have only one lesion length of no more than 40 mm and located in an coronary artery with a diameter of ≥ 2.00 mm but ≤ 4.00 mm. 2. All subjects receive clinical follow-up during hospitalization, 30 days and 6 months after surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
189
The Intravascular Lithotripsy System is a single-use, sterile, disposable balloon angioplasty catheter that contains a series of unfocused, electrohydraulic lithotripsy emitters, which convert electrical energy into transient acoustic circumferential pressure pulses that disrupt both superficial and deep calcium within vascular plaque.
The Second Affliated Hospital Ha'erbin Medical University
Harbin, Heilongjiang, China
Procedure success rate
Procedure success is defined as stent implantation with residual diameter stenosis ≤30% and no major adverse cardiac events (MACE) during hospitalization (up to 7 days post-procedure). MACE is defined as the composite of cardiac death, myocardial infarction, and target vessel revascularization.
Time frame: During hospitalization (up to 7 days after procedure)
Device success rate
Device success is defined as delivery of the IVL catheter across the target lesion and delivery of lithotripsy without serious angiographic complications immediately after IVL.
Time frame: Baseline procedure
Angiographic success rate
Angiographic success is defined as stent delivery with ≤30% residual stenosis and without serious angiographic complications.
Time frame: Baseline procedure
MACE freedom rate at 30 days after the index procedure
MACE is defined as a composite of cardiac death, myocardial infarction\[MI\], and target vessel revascularization \[TVR\]. (Periprocedural MI is defined as peak post-PCI CK-MB level \>3 x the upper limit of normal \[ULN\], both non-Q wave myocardial infarction or Q-wave myocardial infarction.)
Time frame: within 30 days of baseline procedure
Procedure-related serious complications
Procedure-related serious complications included severe dissection (Type D-F, according to NHLBI classification system), perforation, abrupt closure, and persistent slow flow/no-reflow during the baseline procedure.
Time frame: Baseline procedure
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