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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
China-Japan Friendship Hospital
RECRUITING
Beijing
Contact Information
Primary
Zhen Zhang, Doctor
bjmuzz@163.com
+86 15210849352
Backup
Zhaoxue Sheng, Doctor
shengzhaoxue@163.com
+86 15600268925
Time Frame
Start Date: 2022-09-13
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 2500
Treatments
Active_comparator: Intrathrombus thrombolysis
Intrathrombus thrombolysis with microcatheter or pierced bolloon during PPCI
Active_comparator: Aspiration thrombectomy
Aspiration thrombectomy during PPCI
Sponsors
Leads: China-Japan Friendship Hospital

This content was sourced from clinicaltrials.gov

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