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Optical Coherence Tomography in Long Lesions

NCT01133925 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2010-05-31

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 assigned to receive multiple zotarolimus eluting stents (Resolute Sprint). The completeness of stent struts coverage and/or late malapposition are evaluated by Optical Coherence Tomography at 6 months follow-up.Data will be compared to the historical arm of ODESSA trial (patients treated with multiple sirolimus-,paclitaxel polymer-or zotarolimus eluting stents).

Conditions

Interventions

DEVICE

Resolute Sprint

Zotarolimus Eluting Stent (Resolute Sprint) implanted in overlap

DEVICE

Sirolimus Eluting Stent

Cypher stents implanted in overlap

DEVICE

Paclitaxel Eluting Stent

Taxus stents implanted in overlap

DEVICE

Zotarolimus eluting stent

Endeavor stents implanted in overlap

Sponsors & Collaborators

  • Case Western Reserve University

    collaborator OTHER

  • Medtronic Vascular

    collaborator INDUSTRY

  • A.O. Ospedale Papa Giovanni XXIII

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-08-31
Completion
2011-05-31

Countries

  • Italy

Study Locations

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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 NCT01133925 on ClinicalTrials.gov