OCT Evaluation 3 Months After Sirolimus Eluting Stent Implantation

NCT ID: NCT02504307

Last Updated: 2018-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Inspiron

Sirolimus Eluting Stent Inspiron

Group Type EXPERIMENTAL

Sirolimus Eluting Stent Inspiron

Intervention Type DEVICE

Angioplasty with Sirolimus Eluting Stent Inspiron implantation

Cronus

Bare Metal Stent

Group Type ACTIVE_COMPARATOR

Bare Metal Stent

Intervention Type DEVICE

Angioplasty with Bare Metal Stent Cronus implantation

Interventions

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Sirolimus Eluting Stent Inspiron

Angioplasty with Sirolimus Eluting Stent Inspiron implantation

Intervention Type DEVICE

Bare Metal Stent

Angioplasty with Bare Metal Stent Cronus implantation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* one or two de novo lesions (\> 50% visual estimation)
* lesion diameter between 2.5 and 3.5 mm
* lesion length up to 33 mm.

Exclusion Criteria

* MI within the last 72 hours
* restenotic lesion.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Scitech Produtos Medicos Ltda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sergio Leandro, MD

Role: PRINCIPAL_INVESTIGATOR

Insituto Nacional de Cardiologia

Locations

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Instituto Nacional de Cardiologia

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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Laranjeiras

Identifier Type: -

Identifier Source: org_study_id

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