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

Xiamen Cardiovascular Hospital, Xiamen University

Status: Enrolling

Conditions: STEMI

Treatments: Device: Angio-guide DCB PTCA; Device: IVUS-guide DCB PTCA

Study type: Interventional

Funder types: Other

Identifiers

NCT04475978

2020YLK5

Details and patient eligibility

About

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.

Enrollment: 208 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute myocardial infarction eligible for PPCI:

  1. >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) .
  2. Reperfusion is expected to be feasible within 12 h after onset of complaints.

• Infarct related artery eligible for PPCI and:

  1. De novo lesion in a native coronary artery
  2. Reference-vessel diameter 2.5 mm and 4 mm
  3. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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208 participants in 2 patient groups, including a placebo group

IVUS group

Experimental group

Treatment:

Device: IVUS-guide DCB PTCA

Angio group

Placebo Comparator group

Treatment:

Device: Angio-guide DCB PTCA