Use of Export in Primary Percutaneous Coronary Intervention

ST-segment Elevation Myocardial Infarction (STEMI) Clinical Trial

— EPISOO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05510661
• Other study ID #: ERC-63/2021
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: May 31, 2026

Study information

• Verified date: March 2024
• Source: National Institute of Cardiovascular Diseases, Pakistan
• Contact: Dr Faiza Farooq, FCPS
• Phone: +923002426460
• Email: drffaziz[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Export Catheter
Manual thrombus aspiration with the use of export catheter during primary PCI
• Balloon catheter
Predilatation with balloon catheter

Locations

Country	Name	City	State
Pakistan	National Institute of Cardiovascular Diseases	Karachi	Sindh

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Cardiovascular Diseases, Pakistan	Medtronic

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

Kumar D, Saghir T, Sial JA, Kumar R, Karim M, Huma ZE, Qamar N. Use of export vs. balloon in primary percutaneous coronary intervention, in-hospital outcomes and optimal export time. Journal of the American College of Cardiology. 2021 May 11; 77(18_Supple

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post thrombus aspiration TIMI flow	Immediate TIMI flow after export/balloon	Immediately after export/balloon
Primary	Slow/No-reflow	TIMI 0-II flow	Immediately after procedure
Primary	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