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Safety and Efficacy of the Pe...

Safety and Efficacy of the Percutaneous Intervention Performed With Devices of a Single-brand

Last Updated: 2012-07-04

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

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Brief Summary

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The freedom of choice in medicine is based on the physician's ability to treat their patients with the best available therapy. The armamentarium for percutaneous intervention is frequently determined on the basis of subjective criteria and the experience of the interventional cardiologist. The evaluation of devices used in coronary intervention, especially angiography and its clinical outcomes, has rarely been investigated; the exceptions are studies on stents. Therefore, the freedom of choice for the interventional cardiologist has been challenged, especially because of cost restrictions. This way this study aims to assess the safety and efficacy of a device of a single brand in performing percutaneous transluminal coronary angioplasty (guide catheters, guidewires, balloons, and stents) in selected patients.

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Detailed Description

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Conditions

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Atherosclerotic Heart Disease Coronary Heart Disease

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Coronary stent - Tsunami

A coronary angioplasty was done

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

The study included both male and female patients for stent implantation referred for angioplasty of coronary arteries with more than 18 years.

Exclusion Criteria

* chronic total occlusion angioplasty,
* saphenous graft angioplasty,
* bifurcation angioplasty (lateral branch greater than 1.5 mm)
* plans to perform angioplasty on more than one vessel during the same procedure
* and primary angioplasty in acute myocardial infarction

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers