Use of Export in Primary Percutaneous Coronary Intervention (EPISOO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: ST-segment Elevation Myocardial Infarction (STEMI); Total Occlusion of Coronary Artery; Primary Percutaneous Coronary Intervention
• Intervention / Treatment: Device: Export Catheter; Device: Balloon catheter

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Faiza Farooq, FCPS; Phone Number: +923002426460; Email: drffaziz@gmail.com
• Study Contact Backup: Name: Tahir Saghir, FCPS; Phone Number: +923002199844; Email: tahirsaghir@gmail.com

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75510
      • Recruiting
      • National Institute of CardioVascular Diseases
      • Contact: Dr Faiza Farooq, FCPS; Phone Number: 923002426460; Email: drffaziz@gmail.com
      • Contact: Dr Tahir Saghir; Phone Number: +9299201271; Email: tahirsaghir@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Institute of Cardiovascular Diseases, Pakistan
• Collaborators: Medtronic
• Investigators: Principal Investigator: Dr Fiaza Farooq, FCPS, National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan

Publications and helpful links

General Publications

• 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_Supplement_1): 1034.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: August 19, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: ERC-63/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes