Use of Export in Primary Percutaneous Coronary Intervention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2026-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

RESOLUTE Japan SVS: The Clinical Evaluation of the MDT-4107 DES in the Treatment of De Novo Lesions in Small Diameter Native Coronary Arteries

NCT01150500

Arterial Occlusive Diseases Myocardial Ischemia Cardiovascular Diseases +1 more

COMPLETED NA

EXecutive RCT: Evaluating XIENCE V® in a Multi Vessel Disease

NCT00531011

Coronary Disease Coronary Artery Disease Coronary Artery Stenosis +1 more

COMPLETED PHASE4

Prospective, Single-arm, Multicenter Study for Evaluation the Safety and Effectiveness of the ALEX Stent in a Real-world Setting of Percutaneous Coronary Interventions in Patients With Coronary Heart Disease

NCT01637012

Stable Angina Unstable Angina Myocardial Infarction

COMPLETED PHASE4

Bioabsorbable Scaffold vs Drug-coated Balloon for Coronary de Novo Lesions in STEMI: Prospective Observational Trial

NCT04565561

Cardiovascular Diseases

UNKNOWN

Primary FIbrinolysis and Secondary STenting Versus immEdiate Stenting in ST-segment Elevation Myocardial Infarction

NCT04663932

Coronary Artery Disease Myocardial Ischemia Acute Coronary Syndrome +7 more

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Group

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

Group Type EXPERIMENTAL

Export Catheter

Intervention Type DEVICE

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

Control group

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

Group Type ACTIVE_COMPARATOR

Balloon catheter

Intervention Type DEVICE

Predilatation with balloon catheter

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Export Catheter

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

Intervention Type DEVICE

Balloon catheter

Predilatation with balloon catheter

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Thrombus Aspiration

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No