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Rheolytic Thrombectomy in Patients With Acute STEMI and Large Thrombus Burden

NCT02604394 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2015-11-17

No results posted yet for this study

Summary

Coronary obstruction by an occlusive thrombus complicating a ruptured or eroded atherosclerotic plaque is the most frequent pathologic substrate of acute myocardial infarction (AMI).

Timely restoration of perfusion and thereby myocardial salvage is the single most important objective in the management of patients with ST segment-elevation myocardial infarction (STEMI).

To address these uncertainties, our study aims to evaluate the role of RT in patients who are most likely to benefit from it (thrombus grade 4 and 5) using a sensitive, quantitative, and reproducible parameter; CMR-derived myocardial salvage. also, to determine whether Rheolytic Thrombectomy (RT) before conventional PCI to the culprit vessel as compared to conventional PCI (with or without MTA) results in improved myocardial salvage; and to identify clinical and angiographic determinants of any difference observed between both treatment groups.

Conditions

  • ST Elevation Myocardial Infarction
  • STEMI

Interventions

PROCEDURE

Rheolytic Thrombectomy

RT will be performed with the The AngioJet rheolytic thrombectomy system (Medrad Interventional/Possis, Minneapolis, Minnesota). The RT system includes three units: disposable catheter, disposable pump set and a reusable drive unit: 1. The single-use catheter has two lumens; one allows for the in-flow of high velocity saline jets through the catheter tip, and the other allows for the evacuation of thrombotic debris and passage of a guidewire. 2. The disposable pump connects to a bag of heparinized saline. 3. The drive unit pumps pressurized heparinized saline at 10,000 psi at the tip of the catheter,

PROCEDURE

Conventional PCI

In patients in the conventional PCI group, antegrade flow in the culprit vessel will be established with conventional PCI with preference of direct stenting and use of manual thrombus aspiration when deemed necessary by the operator.

Sponsors & Collaborators

  • Magdi Yacoub Heart Foundation

    lead OTHER

Principal Investigators

  • David Antoniucci, MD, Interventional Cardiology · Head of Interventional Cardiology Dept., Careggi Hospital - University of Florence, Italy.

  • Ahmed M ElGuindy, MD, MRCP · Head of Cardiology Dept. at Aswan Heart Centre - Magdi Yacoub Heart Foundation - Aswan, Egypt.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-10-31
Completion
2017-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02604394 on ClinicalTrials.gov