Intravascular Ultrasound Guided Drug Eluting Stents Implantation in All-comers Coronary Lesions （ULTIMATE Trial）

Study Overview
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Brief Summary
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A number of 1448 patients scheduled for elective percutaneous coronary intervention (PCI) with a native coronary stenosis suitable for DES implantation and IVUS imaging are openly randomized 1:1 to either IVUS guidance or angiographic guidance groups.

Detailed Description
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The study is prospectively conducted at 8 high-volume PCI centers in China with IVUS expertise. Clinic follow-up are planned in all patients 12 months after implantation of drug eluting stents. Primary endpoint is target vessel failure. The study is powered for primary endpoint, which are likely to reach significance at the level P < 0.05 even at a follow-up drop-out rate up to 10%.

Official Title
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Intravascular Ultrasound Guided Drug Eluting Stents Implantation in All-comers Coronary Lesions （ULTIMATE Trial）

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Angiography
* Procedure: IVUS
* Procedure: DES implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent prior to any study specific procedures; Men and women 18 years and older;. Established indication to PCI according to the guidelines of American Heart Association and American College of Cardiology; Native coronary lesion suitable for drug-eluting stent placement and IVUS imaging. Exclusion Criteria: Pregnancy and breast feeding mother; Co-morbidity with an estimated life expectancy of < 50 % at 12 months; Scheduled major surgery in the next 12 months; Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk; Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 30 days; Known allergy against ticagrelor, or against clopidogrel, or aspirin History of major hemorrhage (intracranial, gastrointestinal, etc.); Chronic total occlusion lesion in either LAD, or LCX or RCA not re-canalized; Severe calcification needing rotational atherectomy； Patient with STEMI (within 24-hour from the onset of chest pain to admission).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IVUS guided DES implantation<br>Stent size and length were selected by online IVUS measurements, and adjunct high-pressure dilation was performed according to the discretion of operators based on the IVUS criteria for stent optimization. | Procedure: IVUS<br>* The size and number of stents and post-dilation will be determined on physician's discrete within the range allowed in this study protocol. All procedure will be performed according to current standard technique. IVUS will be used to assess the anatomic characteristics of lesion and determine appropriate stent size and length. Additional stent implantation or post dilation will be allowed according to attending physician's discrete based on IVUS results.<br>* Other names: Intravascular ultrasound;Procedure: DES implantation<br> <br> * Other names: Percutaneous coronary drug-eluting stents implantation;|
| Active Comparator: Angiography guided DES implantation<br>Stent size and length were chosen by visual estimation, and adjunct high-pressure dilation was performed if an optimal result was not achieved, which was defined as angiographic residual diameter stenosis 20% and absence of angiographically detected dissection. | Procedure: Angiography<br>* The size and number of stents and post-dilation will be determined on physician's discrete within the range allowed in this study protocol. All procedure will be performed according to current standard technique. Additional stent implantation or post dilation will be allowed according to attending physician's discrete. IVUS will be not used in this arm.<br>Procedure: DES implantation<br> <br> * Other names: Percutaneous coronary drug-eluting stents implantation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Vessel Failure | The occurrence of cardiac death, target vessel myocardial infraction and target vessel revascularization. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | the occurrence of 1-year all cause death | 12 months | 
| Cardiac death | Death that could not be attributed to a noncardiac etiology was considered cardiac death. | 12 months | 
| Myocardial infarction | Myocardial infarction was diagnosed by electrocardiographic changes and/or a rise and fall of creatine kinase-myocardial band fraction in the presence of ischemic symptoms. | 12 months | 
| Target vessel revascularization | Target vessel revascularization was defined as repeated revascularization by PCI or surgery of the target vessel. | 12 months | 
| Target lesion revascularization | Target lesion revascularization was defined as any revascularization procedure performed at the site of the treated lesion associated with clinical and/or objective evidence of inducible myocardial ischemia. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous coronary intervention, Drug-eluting stent, Intravascular ultrasound