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TRANSFORM OCT TRiple Assessment of Neointima Stent FOrmation to Reabsorbable polyMer With Optical Coherence Tomography

NCT01972022 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2015-07-03

No results posted yet for this study

Summary

First prospective randomized controlled study to evaluate in an 'all-comers' population with coronary artery disease whether treatment with a novel everolimus eluting stent (EES) with a biodegradable polymer is superior to a durable polymer zotarolimus eluting stent (ZES), with respect to the long term vascular response to treatment These data are important to ascertain the superiority of a new generation DES with bioabsorbable polymer coating to reduce the long term development of in-stent neoatherosclerosis.

Conditions

  • Coronary Artery Lesions

Interventions

DEVICE

EES SYNERGY™

percutaneous coronary intervention with implantation of Bioabsorbable Polymer EES

DEVICE

ZES, RESOLUTE Integrity™

percutaneous coronary intervention using ZES, RESOLUTE Integrity™ coronary stent

Sponsors & Collaborators

  • A.O. Ospedale Papa Giovanni XXIII

    lead OTHER

Principal Investigators

  • Giulio Guagliumi, MD · A.O. Papa Giovanni XXIII, Cardiovascular Department

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-03-31
Completion
2016-09-30

Countries

  • Italy

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 NCT01972022 on ClinicalTrials.gov