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OCT Evaluation 3 Months After Sirolimus Eluting Stent Implantation

NCT02504307 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2018-08-14

No results posted yet for this study

Summary

Prospective, single center, randomized and non-inferiority study, to include up to 60 patients with de novo coronary artery disease. Patients will be followed at 30 days, 3, 6 and 12 months. At 3 months all patients will be submitted to angiographic and OCT evaluation.

Conditions

Interventions

DEVICE

Sirolimus Eluting Stent Inspiron

Angioplasty with Sirolimus Eluting Stent Inspiron implantation

DEVICE

Bare Metal Stent

Angioplasty with Bare Metal Stent Cronus implantation

Sponsors & Collaborators

  • Scitech Produtos Medicos Ltda

    lead INDUSTRY

Principal Investigators

  • Sergio Leandro, MD · Insituto Nacional de Cardiologia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • Brazil

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 NCT02504307 on ClinicalTrials.gov