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

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.

Study Overview

• Status: Recruiting
• Conditions: STEMI
• Intervention / Treatment: Device: IVUS-guide DCB PTCA; Device: Angio-guide DCB PTCA

• Study Type: Interventional
• Enrollment (Anticipated): 208
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiang Chen, MD; Phone Number: 18033997788; Email: Seanchenx@126.com

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361000
      • Recruiting
      • Xiamen Cardiovascular Hospital Xiamen University
      • Contact: Bin Wang, Ph.D; Phone Number: +8613400664305; Email: mocw361@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IVUS group	Device: IVUS-guide DCB PTCA; IVUS-guide DCB PTCA
Placebo Comparator: Angio group	Device: Angio-guide DCB PTCA; Angio-guide DCB PTCA

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xiamen Cardiovascular Hospital, Xiamen University
• Investigators: Principal Investigator: Yulin Zhou, Ph.D, Clinical Trial Center of Xiamen Cardiovascular Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2020
• Primary Completion (Anticipated): January 31, 2023
• Study Completion (Anticipated): March 30, 2023

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (Actual): July 17, 2020

Study Record Updates

• Last Update Posted (Actual): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 29, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: STEMI; drug-coated balloon; IVUS
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: 2020YLK5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No