Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT05554588

Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary PCI

Led by China-Japan Friendship Hospital · Updated on 2022-09-26

2500

Participants Needed

1

Research Sites

207 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is an multicenter, randomized, controlled, parallel group study. ST-Segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden(HTB) will be allocated to one of the following: intrathrombus thrombolysis or manual aspiration thrombectomy during primary percutaneous coronary intervention(PPCI).

CONDITIONS

Official Title

Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary PCI

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with myocardial ischemia symptoms lasting 30 minutes or more
  • Definite ECG changes indicating STEMI (ST elevation >0.1 mV in two limb leads or >0.2 mV in two precordial leads)
  • Referred for primary percutaneous coronary intervention (PPCI)
  • Within 12 hours of symptom onset, or 12-24 hours with persistent symptoms, hemodynamic instability, or fatal arrhythmia
  • High thrombus burden defined by TIMI thrombus grade 3 or 4 after angiography, or grade ≥3 after guidewire crossing or predilation if initial grade 5
  • Provided informed consent
Not Eligible

You will not qualify if you...

  • Rescue PCI after systemic thrombolysis
  • Previous coronary artery bypass graft (CABG) surgery
  • Life expectancy less than 1 year
  • Active bleeding in past 6 months, bleeding disorders, or prone to bleeding
  • Serious liver or kidney dysfunction
  • Pregnancy or breastfeeding
  • Uncontrolled high blood pressure (greater than 180/100 mmHg)
  • Previous hemorrhagic or ischemic stroke within past 3 months
  • Cardiogenic shock or requiring cardiopulmonary resuscitation
  • Unable to provide informed consent or complete follow-up

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China, 100029

Actively Recruiting

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Research Team

Z

Zhen Zhang, Doctor

CONTACT

Z

Zhaoxue Sheng, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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