NCT04475978

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 17, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

November 1, 2022

Status Verified

July 1, 2022

Enrollment Period

2.7 years

First QC Date

July 9, 2020

Last Update Submit

October 29, 2022

Conditions

STEMI

Keywords

STEMIdrug-coated balloonIVUS

Outcome Measures

Primary Outcomes (1)

  • late lumen loss（LLL）

    late lumen loss（LLL）

    At 9 months follow-up

Secondary Outcomes (1)

  • target lesion failure (TLF)

    At 1-year follow-up

Study Arms (2)

IVUS group

EXPERIMENTAL
Device: IVUS-guide DCB PTCA

Angio group

PLACEBO COMPARATOR
Device: Angio-guide DCB PTCA

Interventions

IVUS-guide DCB PTCADEVICE

IVUS-guide DCB PTCA

IVUS group
Angio-guide DCB PTCADEVICE

Angio-guide DCB PTCA

Angio group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \- 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
  • Planned major surgery within 6 weeks
  • Expected mortality from any cause within the next 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiamen Cardiovascular Hospital Xiamen University

Xiamen, Fujian, 361000, China

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Yulin Zhou, Ph.D

    Clinical Trial Center of Xiamen Cardiovascular Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiang Chen, MD

CONTACT

18033997788Seanchenx@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2020

First Posted

July 17, 2020

Study Start

May 25, 2020

Primary Completion

January 31, 2023

Study Completion

March 30, 2023

Last Updated

November 1, 2022

Record last verified: 2022-07

Locations

CN(1)