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

  • STATUS
    Recruiting
  • End date
    Mar 30, 2023
  • participants needed
    208
  • sponsor
    Xiamen Cardiovascular Hospital, Xiamen University
Updated on 24 January 2021

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 angiography for ST-segment elevated myocardial infarction STEMIpatients.

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.

Details
Condition STEMI
Treatment IVUS-guide DCB PTCA, Angio-guide DCB PTCA
Clinical Study IdentifierNCT04475978
SponsorXiamen Cardiovascular Hospital, Xiamen University
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
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