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The IVUS-CKD study is a prospective, randomized controlled, multicenter trial to determine whether the intravascular ultrasound (IVUS)-guided percutaneous coronary intervention is superior to the angiography-guidance in chronic kidney disease (CKD) patients with respect to target vessel failure (TVF) at 12 months after randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVUS-guidance PCI | Experimental | In the IVUS-guidance group, the optimal stent deployment criteria for non-left main lesion will include the following: : (1) the minimal lumen area (MLA) in the stented segment > 5.0 mm^2 or > 90% of the MLA at the distal reference segments, (2) plaque burden 5 mm proximal or distal to the stent edge is < 55%, and (3) absence of medial dissection over 3 mm in length. In the setting of a two-stent approach for distal left main bifurcation lesions, the optimal stent deployment criteria are an absolute minimal stent area (MSA) greater than 8 mm^2 for the left main, greater than 7 mm^2 for carina, greater than 6 mm^2 for the ostial or proximal left anterior descending artery, and greater than 5 mm^2 for the ostial or proximal left circumflex artery. For left main lesion treated with single-stent technique, the criteria are greater than 7mm^2 for distal and greater than 8mm^2 for proximal. Further treatment will be required if the criteria are not met. |
|
| Angiography-guidance PCI | Active Comparator | Angiographic success is defined as thrombolysis in myocardial infarction (TIMI) flow grade 3, and residual stenosis < 20%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous coronary intervention | Procedure | PCI with DES implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target vessel failure (TVF), including cardiac death, target vessel myocardial infarction (MI), or clinically driven target vessel revascularization (TVR) | The difference in TVF will be calculated from 0 month to 12 months between IVUS- and Angiography-guidance groups. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hierarchical composite of target vessel failure | Hierarchical composite of cardiac death, target vessel MI, or clinically driven target vessel revascularization after randomization analyzed by win ratio method. | 12 months |
| 30-day cardiorenal endpoint |
| Measure | Description | Time Frame |
|---|---|---|
| Renal outcomes | A composite of requiring specific treatment for acute renal failure (continuous renal replacement therapy, or dialysis), chronic dialysis (peritoneal dialysis, or hemodialysis), persistent decline in eGFR, or renal death. | 12 months |
| Annual change in eGFR from baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ning Guo, PhD,MD | Contact | +86 13991229101 | nguomd@mail.xjtu.edu.cn | |
| Xin Huang, PhD,MD | Contact | +86 13571961135 | hearthx@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Ning Guo | The First Affiliated of Xi'an Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hopital of Xi'an Jiaotong University | Recruiting | Xi'an | Shaanxi | 710061 | China |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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A composite of contrast-associated acute kidney injury (CA-AKI), requiring specific treatment for acute renal failure, persistent decline in eGFR, MI, or all-cause death.
| 30 days |
| Target vessel failure excluding periprocedural MI | The difference will be calculated from 0 month to 12 months between IVUS- and Angiography guidance groups. | 12 months |
| Cardiac death | Death that could not be attributed to a noncardiac etiology is considered cardiac death. | 12 months |
| Target vessel MI | 12 months |
| Clinically driven target vessel revascularization | Any clinically driven repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion. | 12 months |
| Spontaneous MI | 12 months |
| Target lesion failure | A composite of cardiac death, target vessel related MI, or clinically driven target lesion revascularization. | 12 months |
| Clinically driven target lesion revascularization | 12 months |
| Major adverse cardiovascular event | A composite of cardiac death, MI, definite stent thrombosis (ST), or clinically driven TVR | 12 months |
total slope |
| 12 months |
| Clinically relevant bleeding | Bleeding Academic Research Consortium Definition for Bleeding types 2，3 or 5 | 12 months |
| Major bleeding | Bleeding Academic Research Consortium Definition for Bleeding types 3 or 5 | 12 months |
| All-cause death | 12 months |
| Definite or probable stent thrombus (ST) | ST was classified as definite, probable, or possible, according to the definitions provided by the Academic Research Consortium (ARC). | 12 months |
| Procedure time | From first wire insertion to guide catheter removal. | during PCI |
| Radiation exposure | From first wire insertion to guide catheter removal. | during PCI |
| Total amount of contrast use | From first wire insertion to guide catheter removal. | during PCI |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019060 | Minimally Invasive Surgical Procedures |