NCT05043597

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

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
3,838

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 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

March 1, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 14, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

2.8 years

First QC Date

August 25, 2021

Last Update Submit

September 4, 2021

Conditions

STEMI

Outcome Measures

Primary Outcomes (1)

  • Adverse cardiovascular events

    Including cardiogenic death, recurring myocardial infarction Stent thrombosis or target vessel revascularization

    3 years

Study Arms (2)

Thrombus aspiration

EXPERIMENTAL
Procedure: Thrombus aspiration

control group

NO INTERVENTION

Interventions

Thrombus aspirationPROCEDURE

Thrombus aspiration

Thrombus aspiration

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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).

You may not qualify if:

  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen People's Hospital

Shenzhen, China

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2021

First Posted

September 14, 2021

Study Start

March 1, 2020

Primary Completion

January 1, 2023

Study Completion

February 28, 2023

Last Updated

September 14, 2021

Record last verified: 2021-09

Locations

CN(1)