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This is a prospective, multicenter, single-arm registry study, aimed to evaluate the clinical outcomes of using Shockwave IVL catheter in the treatment of coronary artery calcification in real-world clinical practice.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shockwave Coronary Intravascular Lithotripsy (IVL) catheter | Device | Patients with coronary artery calcification who are planned to undergo PCI and are deemed in need of Shockwave IVL catheter treatment by their physicians. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure success | Procedure success defined as successful stent implantation, residual stenosis degree <30% (core laboratory), and no major adverse cardiac events (MACE) occurring during hospitalization | in 48 hours post-procedure or prior to discharge, whichever comes first |
| Freedom from major adverse cardiac events (MACE) within 30 days of the index procedure | MACE is defined as: Cardiac death; or Myocardial Infarction (MI): Follow the Fourth Universal Definition of Myocardial Infarction ; or Target Vessel Revascularization (TVR) defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure; or Target lesion thrombosis. | 30 days post index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Vascular complications in the proudure | Vascular complications is defined as: Perforation or Severe dissection or Acute occlusion or Consistent No-reflow/ slow flow | Immediately post index procedure |
| Incidence of target lesion revascularization |
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Inclusion Criteria:
Exclusion Criteria:
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All patients with coronary artery calcification who are planned to undergo percutaneous coronary intervention (PCI) and are deemed suitable to receive Shockwave IVL catheter treatment by their physicians.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| liuzhou People's Hospital | Liuzhou | Guangxi | China | |||
| Yulin First People's Hospital |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D002114 | Calcinosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D057785 | Catheters |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| 30 days post index procedure |
| Incidence of target lesion revascularization | 6 months post index procedure |
| 30 days post index procedure | 9 months post index procedure |
| Incidence of target lesion revascularization | 12 months post index procedure |
| Yulin |
| Guangxi |
| China |
| The First Affiliated Hospital of Guangxi Medical University | Nanjing | Guanxi | China |
| Guilin People's Hospital | Guilin | China |
| Guiping People's Hospital | Guiping | China |
| Liuzhou labors' Hospital | Liuzhou | China |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |