Clinical trial NCT04475978: Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon Treatment for STEMI Patients：a Prospective, Multicenter, Randomized Controlled Trial
Official title: Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon Treatment for STEMI Patients：a Prospective, Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: STEMI
Keywords: STEMI
drug-coated balloon
IVUS
Lead sponsor: Xiamen Cardiovascular Hospital, Xiamen University
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: late lumen loss（LLL）
timeFrame: At 9 months follow-up
Secondary outcomes:
measure: target lesion failure (TLF)
timeFrame: At 1-year follow-up
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Xiamen Cardiovascular Hospital Xiamen University
state: Fujian
Study officials:
affiliation: Clinical Trial Center of Xiamen Cardiovascular Hospital
name: Yulin Zhou, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: