Latin America Real World Study With Inspiron Drug Eluting Stent - INSPIRON LATITUDE

NCT ID: NCT03471234

Last Updated: 2023-05-18

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

Total Enrollment

299 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-03

Study Completion Date

2022-08-02

Brief Summary

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Prospective, multicenter, single arm registry to monitor post-market clinical outcomes of patients treated with Inspiron Sirolimus-Eluting Stent with Biodegradable Polymer.

Detailed Description

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Prospective, multicenter, single arm registry to assess the safety and performance of Inspiron Sirolimus-Eluting Stent with Biodegradable Polymer for the treatment of "real world" patients.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Angioplasty

Inspiron Drug Eluting stent implantation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All individuals aged over 18 years who signed the informed consent and had lesions in native coronary arteries treated only with Inspiron Sirolimus-Eluting stent.

Exclusion Criteria

* Saphenous vein grafts or Mammary lesions;
* Individuals who have been treated within the last 6 months with another stent;
* Acute myocardial infarction with ST segment elevation;
* Chronic Total Occlusion
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

Locations

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Instituto Dante Pazzanese de Cardiologia

São Paulo, , Brazil

Site Status

Instituto do Coração - INCOR

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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SCI-CO-01

Identifier Type: -

Identifier Source: org_study_id

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