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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04475978

Enrollment

208

Registered

2020-07-17

Start date

2020-05-25

Completion date

2023-03-30

Last updated

2022-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

STEMI

Keywords

STEMI, drug-coated balloon, IVUS

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 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.

Interventions

DEVICEIVUS-guide DCB PTCA

IVUS-guide DCB PTCA

DEVICEAngio-guide DCB PTCA

Angio-guide DCB PTCA

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
late lumen loss（LLL）	At 9 months follow-up	late lumen loss（LLL）

Secondary

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

Countries

China

Contacts

Primary ContactXiang Chen, MD

Seanchenx@126.com18033997788

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026