To evaluation of the efficacy and safety of an aspiration catheter in patients undergoing PCI for acute ST-segment elevation myocardial infarction (STEMI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
144
Thrombus aspiration using Aspiration Catheter
Thrombus aspiration using Export Advance Aspiration Catheter
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGThe rate of TIMI flow grad 3 after PCI
Defined as the percentage of subjects with TIMI flow graded 3 after PCI.
Time frame: Immediately after procedure
TIMI flow after PCI
Target vessel TIMI (Thrombolysis In Myocardial Infarction) flow grad after PCI, after completion of of coronary thrombus using the test device or control device to complete thrombus aspiration
Time frame: Immediately after procedure
MBG
MBG (Myocardial Blush Grade) after coronary thrombus aspiration using either the test device or the control device. There are 4 levels of MBG. Grades range from 0 and up to 3, with higher grades being better.
Time frame: Immediately after procedure
TIMI Thrombus Grade
TIMI Thrombus Grade after coronary thrombus aspiration using either the test device or the control device. There are 6 levels of MBG. Grades range from 0 and up to 5, with higher grades being worse.
Time frame: Immediately after procedure
STR(ST-segment resolution) at 90 minutes
The index of change in the highest level of ST-segment elevation relative to the highest level of preoperative ST-segment elevation was assessed on the basis of electrocardiographic at 90 min ± 30 min after PCI.
Time frame: Day 0
Thrombus aspiration time and number of aspirations
Record and compare the total thrombus aspiration time and number of aspirations in both groups.
Time frame: Immediately after procedure
Device technical success rate
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The test device or control device is able to successfully pass through all target lesions, complete thrombus aspiration, and successfully withdraw without complications relate to the procedure during thrombus aspiration, and TIMI flow grade 3 in the immediately after PCI.
Time frame: Immediately after procedure
MACE
MACE includes cardiovascular death, recurrent myocardial infarction, all strokes, and target vessel revascularization (TVR)
Time frame: 30-day follow-up after procedure
AE and SAE
Incidence of all adverse events, serious adverse events in both groups
Time frame: 30-day follow-up after procedure