Effectiveness Evaluation in Thrombus Aspiration in Patien... | NCT05043597

Studies
Effectiveness Evaluation in Thrombus Aspiration in Patients With STEMI and High Thrombotic Load

NCT05043597

Sponsor

Shenzhen People's Hospital

Status

Unknown status

Last Update Posted

Sep 14, 2021Actual

Enrollment

3,838Estimated

Phase

Not Applicable

Conditions

STEMI

Interventions

Thrombus aspiration

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2020Actual

Primary Completion Date

Jan 1, 2023Estimated

Completion Date

Feb 28, 2023Estimated

First Submitted Date

Aug 25, 2021

First Submission Date that Met QC Criteria

Sep 4, 2021

First Posted Date

Sep 14, 2021Actual

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

Sep 4, 2021

Last Update Posted Date

Sep 14, 2021Actual

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

This study intends to evaluate thrombus on the basis of different methods for evaluating thrombus load The effect of aspiration on the prognosis of STEMI patients with high thrombotic load Provide a basis for the standardized use of aspiration; at the same time, discover the best benefit groups for thrombus aspiration

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

3,838Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thrombus aspiration	Experimental		Procedure: Thrombus aspiration
control group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thrombus aspiration	Procedure	Thrombus aspiration	Thrombus aspiration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse cardiovascular events	Including cardiogenic death, recurring myocardial infarction Stent thrombosis or target vessel revascularization	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

(1) Age ≥ 18 years; (2) Voluntary signing of informed consent; (3) Onset of 12 hours STEMI patients who underwent PCI reperfusion therapy within time; (4) The guidewire passes through the lesion and the blood Heavy embolism load (TIMI thrombus classification ≥ 3).

Exclusion Criteria:

(1) Hemodynamics is unstable or there is cardiogenic shock; (2) After thrombolytic therapy; (3) The expected survival time is less than 6 months due to non-cardiac diseases; (4) Past trips Coronary artery bypass graft patients; (5) Participate in other drug and device research within 30 days; (6) Before surgery, clear active gastrointestinal bleeding or other contraindications for taking dual antiplatelet drugs (7) Patients deemed unsuitable for enrollment by other researchers

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shenzhen People's Hospital		Shenzhen			China

Condition Browse Module

MeSH Terms

ID	Term
D000072657	ST Elevation Myocardial Infarction

Ancestor Terms

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided