An interventional study of Export Catheter and Balloon catheter in ST-segment Elevation Myocardial Infarction (STEMI), Total Occlusion of Coronary Artery and Primary Percutaneous Coronary Intervention, sponsored by National Institute of Cardiovascular Diseases, Pakistan. Active, not recruiting at 1 site in Pakistan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by National Institute of Cardiovascular Diseases, Pakistan · Not applicable, Interventional, and Treatment
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.
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;
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.
667 studies on the registry are indexed under ST Elevation Myocardial Infarction; 180 are open to participants now.
This study's planned enrollment of 300 is above the median of 194 across 427 interventional studies indexed under ST Elevation Myocardial Infarction.
Browse ST Elevation Myocardial Infarction studies →National Institute of Cardiovascular Diseases, Pakistan is the lead sponsor of 22 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Manual thrombus aspiration (use of export catheter) followed by primary PCI
Device: Export Catheter
Predilatation with balloon catheter (≤2.00 mm diameter) followed by primary PCI
Device: Balloon catheter
Manual thrombus aspiration with the use of export catheter during primary PCI
Also known as: Thrombus Aspiration
Predilatation with balloon catheter
Post thrombus aspiration TIMI flow
Immediate TIMI flow after export/balloon
Time frame: Immediately after export/balloon
Slow/No-reflow
TIMI 0-II flow
Time frame: 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
Time frame: In-hospital, at 1 month, and at 6 months
Plan to share: No
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
ST Elevation Myocardial Infarction→
National Institute of Cardiovascular Diseases, Pakistan