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Randomized Study to Assess the Effect of ThRombus Aspiration on Flow Area in STEMI Patients

NCT01271361 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2012-12-07

No results posted yet for this study

Summary

The purpose of the study it to evaluate whether primary percutaneous coronary intervention (primary PCI) with a new thrombectomy device as compared to primary PCI without thrombectomy increases minimal flow area after stenting for treatment of patients presenting with ST-segment elevation myocardial infarction (STEMI) as assessed by OFDI.

Conditions

Interventions

PROCEDURE

primary PCI with thrombectomy

thrombectomy is performed before implantation of a drug eluting stent

PROCEDURE

primary PCI without thrombectomy

no thrombectomy is performed before the implantation of a drug eluting stent

Sponsors & Collaborators

  • Terumo Europe N.V.

    lead INDUSTRY

Principal Investigators

  • Patrick W Serruys, MD · Erasmus Medical Center, Rotterdam, Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-09-30
Completion
2012-12-31

Countries

  • Denmark
  • France
  • Germany
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

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 NCT01271361 on ClinicalTrials.gov