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Coronary calcified lesion is associated with a poor clinical outcome. Intravascular ultrasound (IVUS) provides anatomic information in detail about reference vessel dimensions and lesion characteristics including severity of diameter stenosis, lesion length, and morphology. Both randomized and observational studies have reported the clinical benefits of IVUS guidance for patients with chronic total occlusion (CTO), long lesions, acute coronary syndrome (ACS) with complex bifurcation lesions. Our previous ULTIMATE trial has demonstrated that IVUS-guided drug-eluting stent (DES) implantation significantly improved clinical outcome in all-comers, particularly for patients who had an IVUS-defined optimal procedure, compared with angiography guidance. However, the benefit of IVUS guidance in coronary severe calcification still remains unknown in the modern DES era.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravascular ultrasound guidance | Experimental |
| |
| Angiography guidance | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravascular ultrasound | Procedure | Pretreatment strategy, stent size, stent landing zone and post-dilation balloon size are depended on intravascular ultrasound. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the rate of target-vessel failure at 12 months | the composite of cardiovascular death, target-vessel myocardial infarction, and clinically driven target-vessel revascularization | 12 months after indexed procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun-Jie Zhang, MD | Contact | 025-52271350 | jameszll@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Shao-Liang Chen, MD | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing First Hospital | Recruiting | Nanjing | Jiangsu | China |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D018084 | Ultrasonography, Interventional |
| D002533 | Cerebral Angiography |
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Angiography | Procedure | Pretreatment strategy, stent size, stent landing zone and post-dilation balloon size are depended on angiography. |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D019060 |
| Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D009485 | Neuroradiography |
| D059906 | Neuroimaging |
| D000792 | Angiography |
| D011859 | Radiography |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D003943 | Diagnostic Techniques, Neurological |
| D008919 | Investigative Techniques |