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
China-Japan Friendship Hospital
2,500 participants
Sep 13, 2022
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria9
- 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
- Referred for PPCI
- Within 12 hours of symptom onset, or 12-24 hours but still suffered from persistent symptom, hemodynamic instability or fatal arrhythmia
- 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
- Informed consent
Exclusion Criteria10
- Rescue PCI after systemic thrombolysis
- Previous CABG history
- Life expectancy<1 year
- Active bleeding in past 6 months, hemorrhagic disorders and prone to bleeding
- Serious hepatic or kidney dysfunction
- Pregnancy and lactation
- Uncontrolled hypertension (>180/100mmHg)
- Previous hemorrhagic stroke or ischemic stroke in past 3 months
- Cardiogenic shock or cardio-pulmonary resuscitation
- Informed consent cannot be obtained or follow-up cannot be completed
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Interventions
Intrathrombus Thrombolysis During Primary PCI
Aspiration Thrombectomy During Primary PCI
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05554588