Intravascular Ultrasound Versus Angiography Guided Drug-c... | NCT04475978

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 25, 2020Actual

Primary Completion Date

Jan 31, 2023Estimated

Completion Date

Mar 30, 2023Estimated

First Submitted Date

Jul 9, 2020

First Submission Date that Met QC Criteria

Jul 15, 2020

First Posted Date

Jul 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 29, 2022

Last Update Posted Date

Nov 1, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

208Estimated

Label	Type	Description	Intervention Names
IVUS group	Experimental		Device: IVUS-guide DCB PTCA
Angio group	Placebo Comparator		Device: Angio-guide DCB PTCA

Name	Type	Description	Arm Group Labels	Other Names
IVUS-guide DCB PTCA	Device	IVUS-guide DCB PTCA	IVUS group
Angio-guide DCB PTCA

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D007238	Infarction
D007511	Ischemia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009336	Necrosis