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Optical Coherence Tomography for Drug Eluting Stent Safety

NCT00693030 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2008-06-06

No results posted yet for this study

Summary

Increasing lesion complexity in percutaneous coronary interventions (PCI) has warranted the use of overlapping drug-eluting stents. Whether the substantial impairment of arterial healing observed at sites of overlap in preclinical pathologic studies persists in patients undergoing PCI is unknown. Consecutive patients with long lesions in native coronary vessels requiring stents in overlap are prospectively randomized to receive multiple sirolimus-,paclitaxel polymer-or zotarolimus eluting stents versus bare metal stents. The completeness of stent struts coverage and/or late malapposition are evaluated by Optical Coherence Tomography at 6 months follow-up

Conditions

Interventions

DEVICE

sirolimus drug eluting coronary stent Cypher™ (Cordis Corp, Johnson & Johnson Co)

comparison of multiple drug eluting stents

DEVICE

paclitaxel polymer drug eluting stent Taxus Libertè™ (Boston Scientific, Natick MS)

comparison of multiple drug eluting coronary stents

DEVICE

zotarolimus drug eluting coronary stent Endeavor™ (Medtronic, Santa Rosa, CA)

comparison of multiple drug eluting coronary stents

DEVICE

Libertè bare metal coronary stent Libertè™ BMS(Boston Scientific, Natick, MS)

comparison of DES in overlap vs BMS in overlap

Sponsors & Collaborators

  • Case Western Reserve University

    collaborator OTHER

  • Medtronic Vascular

    collaborator INDUSTRY

  • Boston Scientific Corporation

    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
2006-08-31
Primary Completion
2008-06-30
Completion
2008-12-31

Countries

  • Italy

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 NCT00693030 on ClinicalTrials.gov