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Vessel Wall Response of the Zotarolimus Drug-eluting Stent Implanted in AMI Assessed by Optical Coherence Tomography

NCT00704561 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2022-05-23

No results posted yet for this study

Summary

The objective of this study is to evaluate the completeness of struts coverage and vessel wall response (strut malapposition, neointima disomogeneities in texture) to the ENDEAVOR drug-eluting stent vs the DRIVER stent (bare metal stent of identical metallic platform) implanted for the treatment of the culprit lesion in ST-elevation acute myocardial infarction (STEMI). To investigate the completeness of the coverage as well as the number of uncovered stent struts per section (embedded, uncovered, malapposed) and the neointima texture, high resolution (\~ 10-15 µm axial) intracoronary optical coherence tomography (OCT)will be used.

Conditions

  • Acute Myocardial Infarction

Interventions

DEVICE

ENDEAVOR® drug-eluting stent (Medtronic, Santa Rosa, CA)

ENDEAVOR® drug-eluting stent implanted in acute myocardial infarction

DEVICE

DRIVER bare metal stent (Medtronic, Santa Rosa, Ca)

DRIVER bare metal stent implanted in acute myocardial infarction

DEVICE

Coronary stent implantation

Comparison of Drug Eluting versus Bare Metal Stent

DEVICE

Bare Metal Coronary Stent

Comaprison between Drug Eluting and Bare Metal Coronary Stents

Sponsors & Collaborators

  • Case Western Reserve University

    collaborator OTHER

  • Medtronic

    collaborator INDUSTRY

  • A.O. Ospedale Papa Giovanni XXIII

    lead OTHER

Principal Investigators

  • Giulio Guagliumi, MD · Cardiovascular Department Ospedali Riuniti di Bergamo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-04-30
Completion
2009-10-31

Countries

  • Italy

Study Locations

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Entities

Companies

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 NCT00704561 on ClinicalTrials.gov