NCT05510661

Use of Export in Primary Percutaneous Coronary Intervention

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: National Institute of Cardiovascular Diseases, Pakistan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Export Catheter	Manual thrombus aspiration with the use of export catheter during primary PCI
DEVICE	Balloon catheter	Predilatation with balloon catheter

Timeline

• Start date: 2024-01-15
• Primary completion: 2025-09-24
• Completion: 2026-05-31
• First posted: 2022-08-22
• Last updated: 2026-04-09

Locations

1 site across 1 country: Pakistan

Regulatory

• FDA-regulated device study