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ThromboAblation in Acute Myocardial Infarction

NCT00650975 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2011-01-20

No results posted yet for this study

Summary

1. Assess whether excimer laser coronary atherectomy (ELCA) before direct infarct-related artery (IRA) stenting results in improved reperfusion success in patients presenting with acute ST wave elevation myocardial infarction (STEMI) and angiographically evident thrombus.
2. Validate an ELCA technique for the treatment of STEMI, at high-volume centers experienced in the treatment of acute myocardial infarction (AMI).

Conditions

  • ST Elevation Acute Myocardial Infarction

Interventions

DEVICE

Laser Thromboablation

Laser Thromboablation using the Spectranetics CVX-300® excimer laser system

DEVICE

PTCA (Direct Stenting)

Balloon predilatation or Direct Stenting using conventional techniques according to local standards and device specific instructions for use

Sponsors & Collaborators

  • Spectranetics Corporation

    collaborator INDUSTRY

  • KCRI

    lead OTHER

Principal Investigators

  • Dariusz Dudek, MD, PhD · Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Completion
2010-01-31

Countries

  • Poland

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 NCT00650975 on ClinicalTrials.gov