ST-segment Elevation Myocardial Infarction (STEMI)EPISOONCT05510661
Use of Export in Primary Percutaneous Coronary Intervention
A study testing Export Catheter and Balloon catheter in people with ST-segment Elevation Myocardial Infarction (STEMI) and Total Occlusion of Coronary Artery, run by National Institute of Cardiovascular Diseases, Pakistan at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST-segment Elevation Myocardial Infarction (STEMI), Total Occlusion of Coronary Artery, Primary Percutaneous Coronary Intervention
- What is being tested?
- Export Catheter and Balloon catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2024to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
National Institute of Cardiovascular Diseases
Karachi, Sindh, 75510
About this study
Official title: 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.
Read the 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
- Being tested
- Export Catheter, Balloon catheter
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Export CatheterDevice
Also called Thrombus Aspiration
Manual thrombus aspiration with the use of export catheter during primary PCI
Balloon catheterDevice
Predilatation with balloon catheter
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Manual thrombus aspiration (use of export catheter) followed by primary PCI Receives: Device: Export Catheter |
| Control group | Active comparator | Predilatation with balloon catheter (≤2.00 mm diameter) followed by primary PCI Receives: Device: Balloon catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post thrombus aspiration TIMI flow
Immediate TIMI flow after export/balloon
Measured: Immediately after export/balloon
Slow/No-reflow
TIMI 0-II flow
Measured: 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
Measured: In-hospital, at 1 month, and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start15 Jan 2024
- Primary completion24 Sep 2025
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ST-segment Elevation Myocardial Infarction (STEMI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Manual thrombus aspiration (use of export catheter) followed by primary PCI
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiovascular Diseases, Pakistan
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Faiza Farooq, National Institute of Cardiovascular Diseases, Pakistan
- Investigators
- Dr Fiaza Farooq, FCPS, Principal investigator, National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510661
- Sponsor's protocol ID
- ERC-63/2021
- Acronym
- EPISOO
- Status last verified
- Apr 2026
- First submitted
- 30 Jun 2021
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Export in Primary Percutaneous Coronary Intervention, In-Hospital and Short-term Outcomes and Optimal Time of Export
- ClinicalTrials.gov ID
- NCT05510661
- Acronym / sponsor ID
- EPISOO / ERC-63/2021
- Conditions
- ST-segment Elevation Myocardial Infarction (STEMI), Total Occlusion of Coronary Artery, Primary Percutaneous Coronary Intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Institute of Cardiovascular Diseases, PakistanUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 24 Sep 2025 (actual)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Manual thrombus aspiration (use of export catheter) followed by primary PCI
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Export CatheterManual thrombus aspiration (use of export catheter) followed by primary PCI |
| Control group | Active comparator | Device: Balloon catheterPredilatation with balloon catheter (≤2.00 mm diameter) followed by primary PCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Export CatheterAlso: Thrombus AspirationManual thrombus aspiration with the use of export catheter during primary PCI | Device | Intervention Group |
| Balloon catheterPredilatation with balloon catheter | Device | Control group |
Primary outcome
Post thrombus aspiration TIMI flow
Time frame: Immediately after export/balloon
Immediate TIMI flow after export/balloon
Slow/No-reflow
Time frame: Immediately after procedure
TIMI 0-II flow
Major adverse cardiac events
Time frame: In-hospital, at 1 month, and at 6 months
It will include All-cause death, Cardiovascular death, Re- infarction, Heart Failure, Cardiogenic shock, Cerebrovascular events, Bleeding events, and Stent thrombosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Results publicationKumar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Fiaza Farooq, FCPS principal investigator
National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Export Catheter and Balloon catheter in people with ST-segment Elevation Myocardial Infarction (STEMI) and Total Occlusion of Coronary Artery, run by National Institute of Cardiovascular Diseases, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post thrombus aspiration TIMI flow (time frame: Immediately after export/balloon). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05510661, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.