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RECRUITINGINTERVENTIONAL

Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary PCI

A Randomized Trial of Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction Patients With High Thrombus Burden

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: 1. Patients presenting with: - Symptoms of myocardial ischemia lasting for ≥ 30 minutes AND - Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads 2. Referred for PPCI 3. Within 12 hours of symptom onset, or 12-24 hours but still suffered from persistent symptom, hemodynamic instability or fatal arrhythmia 4. High thrombus burden: - TIMI thrombus grade 3 or 4 after emergency coronary angiography - Or TIMI thrombus grade ≥3 after guidewire crossing or 1.5mm-diameter predilating the culprit lesion if emergency coronary angiography shows TIMI thrombus grade 5 5. willing to sign a consent form Who Should NOT Join This Trial: 1. Rescue PCI after systemic thrombolysis 2. Previous CABG history 3. Life expectancy\<1 year 4. Active bleeding in past 6 months, hemorrhagic disorders and prone to bleeding 5. Serious hepatic or kidney dysfunction 6. Pregnancy and lactation 7. Uncontrolled hypertension (\>180/100mmHg) 8. Previous hemorrhagic stroke or ischemic stroke in past 3 months 9. Cardiogenic shock or cardio-pulmonary resuscitation 10. willing to sign a consent form cannot be obtained or follow-up cannot be completed Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Patients presenting with: * Symptoms of myocardial ischemia lasting for ≥ 30 minutes AND * Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads 2. Referred for PPCI 3. Within 12 hours of symptom onset, or 12-24 hours but still suffered from persistent symptom, hemodynamic instability or fatal arrhythmia 4. High thrombus burden: * TIMI thrombus grade 3 or 4 after emergency coronary angiography * Or TIMI thrombus grade ≥3 after guidewire crossing or 1.5mm-diameter predilating the culprit lesion if emergency coronary angiography shows TIMI thrombus grade 5 5. Informed consent Exclusion Criteria: 1. Rescue PCI after systemic thrombolysis 2. Previous CABG history 3. Life expectancy\<1 year 4. Active bleeding in past 6 months, hemorrhagic disorders and prone to bleeding 5. Serious hepatic or kidney dysfunction 6. Pregnancy and lactation 7. Uncontrolled hypertension (\>180/100mmHg) 8. Previous hemorrhagic stroke or ischemic stroke in past 3 months 9. Cardiogenic shock or cardio-pulmonary resuscitation 10. Informed consent cannot be obtained or follow-up cannot be completed

Treatments Being Tested

PROCEDURE

Intrathrombus Thrombolysis During Primary PCI

Intrathrombus Thrombolysis During Primary PCI

PROCEDURE

Aspiration Thrombectomy During Primary PCI

Aspiration Thrombectomy During Primary PCI

Locations (1)

China-Japan Friendship Hospital
Beijing, Beijing Municipality, China