Status:
UNKNOWN
Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon Treatment for STEMI Patients：a Prospective, Multicenter, Randomized Controlled Trial
Lead Sponsor:
Xiamen Cardiovascular Hospital, Xiamen University
Conditions:
STEMI
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 angiograph...
Eligibility Criteria
Inclusion
- 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
- \- 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
Key Trial Info
Start Date :
May 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2023
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT04475978
Start Date
May 25 2020
End Date
March 30 2023
Last Update
November 1 2022
Active Locations (1)
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1
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, Fujian, China, 361000