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Outcome of Second Generation Drug-eLuting Stents in Patients With Diabetes Mellitus

NCT01293773 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2014-11-07

No results posted yet for this study

Summary

Design: prospective, randomized, multi-center trial comparing the safety and efficacy in the prevention of target lesion failure (TLF) of second generation paclitaxel- versus ABT578- versus Everolimus- eluting stents Study Population: all consecutive diabetic patients with de novo coronary artery lesions undergoing drug-eluting stent implantation in 2010-12.

Time Course: initial Enrollment: October 2010; end of the Enrollment: December 2012 Primary End-Point: target lesion revascularization (TLF) defined as the occurrence of cardiac death, myocardial infarction and repeated lesion revascularization within 12 months.

Secondary End-Points: 1) impact of glucose level during the first three months following the procedure (assessed by hemoglobin A1C ) on clinically-driven target lesion revascularization; 2)TLF and TLR within 12, 24 and 36 months; 3) comparison 12 months versus prolonged (\> 12 months) of dual antiplatelet therapy

Conditions

Interventions

DEVICE

Taxus Element stent

paclitaxel-eluting stent

DEVICE

Integrity Resolute stent

ABT 578-eluting stent

DEVICE

Xience Prime stent

Everolimus-eluting stent

Sponsors & Collaborators

  • Azienda Ospedaliero-Universitaria di Modena

    collaborator OTHER

  • Policlinico Casilino ASL RMB

    lead OTHER

Principal Investigators

  • Enrico Romagnoli, MD, PhD · Policlinico Casilino

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-10-31
Completion
2012-12-31

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 NCT01293773 on ClinicalTrials.gov