Coronary Artery Calcification
Conditions
Keywords
calcification, coronary artery
Brief summary
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.
Detailed description
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.
Interventions
DEVICEIntravascular Lithotripsy System of Shanghai MicroPort Rhythm
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.
Sponsors
Shanghai MicroPort Rhythm MedTech Co., Ltd.
The Second Affiliated Hospital of Harbin Medical University
Huai'an First People's Hospital
People's Hospital of Xinjiang Uygur Autonomous Region
First Affiliated Hospital Xi'an Jiaotong University
West China Hospital
Wuhan Central Hospital
First Hospital of China Medical University
Shanxi Bethune Hospital
Hebei Provincial People's Hospital
The Second Hospital of Hebei Medical University
Shanxi Cardiovascular Hospital
Shengjing Hospital
Three Gorges Hospital of Chongqing University
The First Hospital of Jilin University
Xiamen Cardiovascular Hospital, Xiamen University
The People's Hospital of Liaoning Province
Shanghai East Hospital
Linfen No.4 People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Clinical Inclusion Criteria: 1. Subjects aged between 18 and 85. 2. Subjects who can undergo percutaneous coronary intervention (PCI). 3. Subjects with asymptomatic evidence of ischemia, stable or unstable angina pectoris, or old myocardial infarction. 4. Left Ventricular Ejection Fraction (LVEF) ≥30% as measured by echocardiography for subjects within 6 months before enrollment. (In case of multiple LVEF results, the data closest to the baseline procedure was taken.) 5. Subjects who are able to understand the purpose of the trial, participate voluntarily or by proxy and indicate by signing the informed consent form that they recognize the risks and benefits described in the informed consent document and are willing to undergo clinical follow-up. Angiography Inclusion Criteria: 1. There is only one target lesion that needs to be treated. 2. The target lesion must be located in a de novo native coronary artery with a reference vessel diameter (RVD) ≥2.00 mm to ≤4.00 mm as visually measured. 3. The target lesion angiography shows a stenosis rate ranging from ≥70% (visually measured) or ≥50% to \<70% with symptoms of ischemia. Ischemic symptoms were defined as any of the following: * Exercise stress test positive * Fractional Flow Reserve (FFR) ≤ 0.8 or iFR \< 0.9 * Minimum lumen area (MLA) ≤ 4.0 mm2 by IVUS or OCT 4. The target lesion length must be less than 40 mm (visually measured). 5. The target lesion must meet one of the following : * During angiography, clear hyperdense opacities can be observed on both sides of the arterial wall when the heart pulsates and does not pulsate * Presence of calcium of ≥270°at one cross-section via IVUS or OCT 6. Target lesion TIMI flow 3 prior to the use of the test device (at baseline or after balloon pre-dilatation). 7. The lesion that 0.014 "guidewire can cross.
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure success rate | During hospitalization (up to 7 days after procedure) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device success rate | Baseline procedure | 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. |
| Angiographic success rate | Baseline procedure | Angiographic success is defined as stent delivery with ≤30% residual stenosis and without serious angiographic complications. |
| MACE freedom rate at 30 days after the index procedure | within 30 days of baseline 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.) |
| Procedure-related serious complications | Baseline procedure | 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. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORBo Yu, M.D.
The Second Affiliated Hospital of Harbin Medical University
Outcome results
None listed