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This study is a prospective, multicenter, single-arm trial designed to investigate the effectiveness and safety of this intravascular lithotripsy system to treat severely calcified coronary lesions before stenting.
Subject Population: Subjects ≥ 18 years of age with de novo, calcified coronary artery lesions presenting with stable, unstable or silent ischemia that are suitable for percutaneous coronary intervention (PCI). 266 subjects at 11 sites will be enrolled.Subjects will be followed through discharge, 30 days, 6months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients underwent Intravascular lithotripsy (IVL) | Experimental | Patients with severely calcified coronary lesions were enrolled and underwent IVL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVL(Sonico-CX) | Device | SONICO-CX® balloon matched 1:1 to the reference vessel diameter, was advanced to the target lesion to pretreat |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success rate | defined as successful stent implantation with ≤30% in-stent residual stenosis and the absence of in-hospital MACE, including cardiac death, MI, and target vessel revascularization | During hospitalization (up to 7 days after operation) |
| Measure | Description | Time Frame |
|---|---|---|
| Angiography success rate | Angiographic success was defined as successful stent implantation with ≤30% in-stent residual stenosis and without serious angiographic complications immediately after IVL, including type D to F severe dissection, perforation, acute occlusion, sustained slow-flow, or no-reflow | Immediately after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Incidence of other adverse events during procedural, before discharge, 30 days and 6 months post-procedural | before discharge, 30 days and 6 months post-procedural |
Inclusion Criteria:
General inclusion criteria
Angiographic Inclusion Criteria
Exclusion Criteria:
Patients who fit any of the following criteria were excluded:
Patients who met any of the following criteria were excluded:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of University of Science and Technology of China, | Hefei | Anhui | lkma@ustc.edu.cn | China | ||
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| Device success rate |
Device success was defined as the IVL catheter successfully crossing the target lesion and delivering lithotripsy without serious angiographic complications immediately following the procedure |
| Immediately after operation |
| MACE events | MACE--a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) | before discharge, 30 days and 6 months post-procedural |
| Guangdong Provincial People's Hospital |
| Guangzhou |
| Guangdong |
| 510080 |
| China |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510120 | China |
| Meizhou People's Hospital | Meizhou | Guangdong | 514000 | China |
| Affiliated Hospital of Zunyi Medical University | Zunyi | Guizhou | 563000 | China |
| Zhongda Hospital, Southeast University | Nanjing | Jiangsu | 210009 | China |
| Zhongshan Hospital, Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| Tongji Hospital, Tongji University | Shanghai | Shanghai Municipality | 200065 | China |
| The Second Affiliated Hospital, Zhejiang University | Hangzhou | Zhejiang | 310009 | China |
| Sir Run Run Shaw Hospital, Zhejiang University | Hangzhou | Zhejiang | 310020 | China |
| Ningbo First Hospital University | Ningbo | Zhejiang | 315000 | China |