Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon Treatment for STEMI Patients：a Prospective, Multicenter, Randomized Controlled Trial

Study Overview
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Brief Summary
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Objectives: The present study aimed to investigate the difference in late luminal loss (LLL) at 9-month after drug-coated balloon (DCB) treatment with intravascular ultrasound (IVUS) versus angiography for ST-segment elevated myocardial infarction （STEMI）patients. Background: In primary percutaneous coronary intervention for STEMI, DCB angioplasty has proved to be a safe and feasible strategy. Compare with angiography guidance, IVUS-guided PCI significantly improve clinical outcome. With IVUS guidance, STEMI patients undergo DCB angioplasty might have be beneficial results. Methods: A total of 208 STEMI patients who required DCB treatment were randomly assigned either an IVUS guidance and angiography guidance group. The primary endpoint was late luminal loss at 9-month. Stent thrombosis (ST) was the safety endpoint.

Official Title
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Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon Treatment for STEMI Patients：a Prospective, Multicenter, Randomized Controlled Trial

Conditions
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STEMI

Intervention / Treatment
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* Device: IVUS-guide DCB PTCA
* Device: Angio-guide DCB PTCA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute myocardial infarction eligible for PPCI: >20 min of chest-pain and at least 1 mm ST-elevation in at least two contiguous leads, a new left bundle branch block or a true posterior myocardial infarction (confirmed by ECG or echocardiography) . Reperfusion is expected to be feasible within 12 h after onset of complaints. Infarct related artery eligible for PPCI and: De novo lesion in a native coronary artery Reference-vessel diameter 2.5 mm and 4 mm Diameter stenosis of >50% (by visual assessment) after thrombus aspiration and pre-dilatation. Exclusion Criteria: - Age <18 yr and >85 yr History of myocardial infarction lesion length > 30m Left Main lesion Ostial lesion None-target vessel need to treat with PCI Severe calcification Severe tortuosity Severe angulation Cardiogenic shock before pre-dilation or any serious cases can not perform IVUS Known contraindication/resistance for bivalirudin, fondaparinux, heparin, aspirin, prasugrel and/or ticagrelor Participation in another clinical study, interfering with this protocol Uncertain Known intracranial disease (mass, aneurysm, AVM, haemorrhagic CVA, ischemic CVA/TIA <6 months before inclusion or ischemic CVA with permanent neurological deficit) Gastrointestinal/urinary tract bleeding <2 months before inclusion Refusal to receive blood transfusion Planned major surgery within 6 weeks Stent implantation <1 week before inclusion Expected mortality from any cause within the next 12 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IVUS group<br> | Device: IVUS-guide DCB PTCA<br>* IVUS-guide DCB PTCA<br>|
| Placebo Comparator: Angio group<br> | Device: Angio-guide DCB PTCA<br>* Angio-guide DCB PTCA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| late lumen loss（LLL） | late lumen loss（LLL） | At 9 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| target lesion failure (TLF) | the composite of car- diac death, target-vessel MI (TVMI), or clinically driven TLR | At 1-year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STEMI, drug-coated balloon, IVUS