NCT05510661

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Jan 2024May 2026

First Submitted

Initial submission to the registry

June 30, 2021

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 15, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Expected
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

June 30, 2021

Last Update Submit

April 8, 2026

Conditions

Primary Percutaneous Coronary InterventionTotal Occlusion of Coronary ArteryST-segment Elevation Myocardial Infarction (STEMI)

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

Manual thrombus aspiration (use of export catheter) followed by primary PCI

Device: Export Catheter

Control group

ACTIVE COMPARATOR

Predilatation with balloon catheter (≤2.00 mm diameter) followed by primary PCI

Device: Balloon catheter

Interventions

Export CatheterDEVICE

Manual thrombus aspiration with the use of export catheter during primary PCI

Also known as: Thrombus Aspiration
Intervention Group
Balloon catheterDEVICE

Predilatation with balloon catheter

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Cardiovascular Diseases

Karachi, Sindh, 75510, Pakistan

Location

Related 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_Supplement_1): 1034.

    RESULT

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Dr Fiaza Farooq, FCPS

    National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinded in-hospital outcomes assessment will be insured by separating patients recruitment and follow-up team and follow-up team will be kept blinded of randomization. All the patients will be assigned a unique identity code and collected data will be stored against the assigned code.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Manual thrombus aspiration (use of export catheter) followed by primary PCI
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Acting Associate Professor

Study Record Dates

First Submitted

June 30, 2021

First Posted

August 22, 2022

Study Start

January 15, 2024

Primary Completion

September 24, 2025

Study Completion (Estimated)

May 31, 2026

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)