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OpenTrials
Completed

NCT Number: NCT02504307

OCT Evaluation 3 Months After Sirolimus Eluting Stent Implantation

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Instituto Nacional de Cardiologia

Rio de Janeiro, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sirolimus Eluting Stent Inspiron

Device

Angioplasty with Sirolimus Eluting Stent Inspiron implantation

Bare Metal Stent

Device

Angioplasty with Bare Metal Stent Cronus implantation

Primary outcomes

  1. Safety

    Time frame: 3 months

    Percentage of strut coverage by OCT

Sponsors and collaborators

Lead sponsor

Scitech Produtos Medicos SA

Industry

Registry information

Official study title

Randomized Evaluation of Vascular Healing After Implantation of Sirolimus Eluting Stent Inspiron™ Versus Its Own Bare Metal Version- An OCT Evaluation After 3 Months Follow-up

Acronym: Laranjeiras

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 21, 2015
Registry last updated
Aug 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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