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

Primary Purpose

STEMI

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

IVUS-guide DCB PTCA

Angio-guide DCB PTCA

About this trial

This is an interventional treatment trial for STEMI focused on measuring STEMI, drug-coated balloon, IVUS

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Xiamen Cardiovascular Hospital Xiamen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IVUS group

Angio group

Arm Description

Outcomes

Primary Outcome Measures

late lumen loss（LLL）

Secondary Outcome Measures

target lesion failure (TLF)

the composite of car- diac death, target-vessel MI (TVMI), or clinically driven TLR

Full Information

NCT ID

NCT04475978

First Posted

July 9, 2020

Last Updated

October 29, 2022

Sponsor

Xiamen Cardiovascular Hospital, Xiamen University

1. Study Identification

Unique Protocol Identification Number

NCT04475978

Brief Title

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

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 25, 2020 (Actual)

Primary Completion Date

January 31, 2023 (Anticipated)

Study Completion Date

March 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xiamen Cardiovascular Hospital, Xiamen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

STEMI

Keywords

STEMI, drug-coated balloon, IVUS

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

208 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IVUS group

Arm Type

Experimental

Arm Title

Angio group

Arm Type

Placebo Comparator

Intervention Type

Device

Intervention Name(s)

IVUS-guide DCB PTCA

Intervention Description

IVUS-guide DCB PTCA

Intervention Type

Device

Intervention Name(s)

Angio-guide DCB PTCA

Intervention Description

Angio-guide DCB PTCA

Primary Outcome Measure Information:

Title

late lumen loss（LLL）

Description

late lumen loss（LLL）

Time Frame

At 9 months follow-up

Secondary Outcome Measure Information:

Title

target lesion failure (TLF)

Description

the composite of car- diac death, target-vessel MI (TVMI), or clinically driven TLR

Time Frame

At 1-year follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiang Chen, MD

Phone

18033997788

Seanchenx@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yulin Zhou, Ph.D

Organizational Affiliation

Clinical Trial Center of Xiamen Cardiovascular Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xiamen Cardiovascular Hospital Xiamen University

City

Xiamen

State/Province

Fujian

ZIP/Postal Code

361000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bin Wang, Ph.D

Phone

+8613400664305

mocw361@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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