Use of Export in Primary Percutaneous Coronary Intervention

Study Overview
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Brief Summary
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Aim of this single center randomized open label trial with blinded in-hospital outcomes assessment is designed with aim to compare manual thrombus aspiration followed by percutaneous coronary intervention (PCI) strategy with PCI alone.

Detailed Description
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Clinical benefit of manual aspiration has been a contentious point of debate and it is Class III indication in current clinical practice guidelines, however, recent observational data by Kumar D et al. showed benefits of usage of export in terms of favorable in-hospital outcomes and lesser complication rate in patients with total occlusion, furthermore, benefits of usage of export was observed to be directly associated with duration of chest pain at the time of thrombus aspiration. However, these observations are limited to immediate and in-hospital outcomes and data regarding efficacy of manual thrombus aspiration are not available. Hence this single center randomized open label trial is designed with specific aim to test the following hypothesis for STEMI patients with total occlusion undergoing primary PCI; Whether use of export catheter reduces in-hospital and short term adverse events Whether use of export reduces slow flow or no reflow Whether use of export reduces the use of intracoronary drugs Whether use of export within 6 hours of symptom onset significantly reduces in-hospital and short term adverse events Consecutively recruited patients will be randomized to either primary PCI with export or primary PCI alone group in 2:1 ratio. Post aspiration immediate TIMI flow will be observed and all the patients will be observed for adverse outcomes (MACE) and complications including slow flow/no-reflow. Follow-up intervals will be at the end of one month of randomization and end of 6 month of randomization.

Official Title
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Use of Export in Primary Percutaneous Coronary Intervention, In-Hospital and Short-term Outcomes and Optimal Time of Export

Conditions
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ST-segment Elevation Myocardial Infarction (STEMI), Total Occlusion of Coronary Artery, Primary Percutaneous Coronary Intervention

Intervention / Treatment
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* Device: Export Catheter
* Device: Balloon catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presenting with:-Symptoms of myocardial ischemia lasting for ≥30 minutes 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 Chest pain < 12 hours duration Total occlusion (TIMI 0 flow) Patients undergoing primary PCI Informed consent Exclusion Criteria: Patients with prior history of cardiac related surgery or intervention Performance of a rescue PCI after thrombolysis Known existence of a disease resulting in a life expectancy of less than 6 months Killip class III, IV

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Manual thrombus aspiration (use of export catheter) followed by primary PCI
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Manual thrombus aspiration (use of export catheter) followed by primary PCI | Device: Export Catheter<br>* Manual thrombus aspiration with the use of export catheter during primary PCI<br>* Other names: Thrombus Aspiration;|
| Active Comparator: Control group<br>Predilatation with balloon catheter (≤2.00 mm diameter) followed by primary PCI | Device: Balloon catheter<br>* Predilatation with balloon catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post thrombus aspiration TIMI flow | Immediate TIMI flow after export/balloon | Immediately after export/balloon | 
| Slow/No-reflow | TIMI 0-II flow | Immediately after procedure | 
| Major adverse cardiac events | It will include All-cause death, Cardiovascular death, Re- infarction, Heart Failure, Cardiogenic shock, Cerebrovascular events, Bleeding events, and Stent thrombosis | In-hospital, at 1 month, and at 6 months |