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The goal of this observational study is to learn about in patients with complex coronary lesions undergoing PCI. The main question[s] it aims to answer are: the clinical efficacy and safety of an IVUS-guided approach in patients with complex coronary lesions undergoing PCI, as well as clinical outcomes up to 2 years. Participants will be treated with IVUS-guided PCI.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The OptiCross High Definition (60 MHz) and OptiCross (40MHz) Intravascular Ultrasound (IVUS) catheter from Boston Scientific | Device | The IVUS-guided PCI procedure includes the use of IVUS before PCI (highly recommended) and after PCI (mandatory) |
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-first-event analysis of these three event including cardiac death, target vessel myocardial infarction will be primarily used for clinical endpoints. | Target-vessel failure defined as a composite of cardiac death, target vessel myocardial infarction*, or clinically indicated target-vessel revascularization at 1 year. It means the time of the patient's occurrence of any of the three events in one year. | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-first-event analysis will be primarily used for clinical endpoints. |
|
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Inclusion Criteria:
The patient must be ≥18 years of age
Patients with an indication for PCI of at least one lesion satisfying any of the following criteria:
Presenting with silent ischemia, stable angina, unstable angina or non-ST-elevation acute coronary syndrome (NSTE-ACS)
All lesions must be suitable for treatment with 2nd generation drug eluting stents (or drug-coated balloons when indicated, e.g., in-stent restenosis, branching of bifurcation lesions)
The patient is willing and able to cooperate with registry procedures and follow-up until registry completion
Subject is able to confirm understanding of risks, benefits and treatment alternatives and he/she provides informed consent prior to any protocol-related procedure, as approved by the appropriate Ethics Committee
Exclusion Criteria:
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IVUS-guided approach in patients with complex coronary lesions undergoing PCI
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chenguang Li, Doctor | Contact | 86+ 13816767665 | li.chenguang@zs-hospital.sh.cn | |
| Junbo Ge, Doctor | Contact | jbge@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan Zhongshan Hospital | Recruiting | Shanghai | China |
Currently,All data of projects will be shared with sponsors and leading site principal investigators. Other site investigators are undecided.
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| full-time process until 2 Year |