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

STEMI Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04475978
• Other study ID #: 2020YLK5
• Status: Recruiting
• Phase: N/A
• Start date: May 25, 2020
• Est. completion date: March 30, 2023

Study information

• Verified date: July 2022
• Source: Xiamen Cardiovascular Hospital, Xiamen University
• Contact: Xiang Chen, MD
• Phone: 18033997788
• Email: Seanchenx[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 208
• Est. completion date: March 30, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• ST Elevation Myocardial Infarction
• STEMI

Intervention

Device:
• IVUS-guide DCB PTCA
IVUS-guide DCB PTCA
• Angio-guide DCB PTCA
Angio-guide DCB PTCA

Locations

Country	Name	City	State
China	Xiamen Cardiovascular Hospital Xiamen University	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Xiamen Cardiovascular Hospital, Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	late lumen loss(LLL)	late lumen loss(LLL)	At 9 months follow-up
Secondary	target lesion failure (TLF)	the composite of car- diac death, target-vessel MI (TVMI), or clinically driven TLR	At 1-year follow-up