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Study to Evaluate the Safety of Cronus® - Cobalt Chromium Coronary Stent

2014-08-27 03:15:04 | BioPortfolio

Summary

The objective this study is evaluate the performance and safety of Chronus® cobalt-chromium coronary stent in patients with "de novo" native coronary artery lesions treated with 19-mm-long stents in long-term 9 months.

Description

The use of coronary stents has optimized the results of coronary balloon angioplasty for two reasons:

1. reduced acute complications, such as acute and subacute occlusion, as well as the need of urgent myocardial revascularization;

2. reduced coronary restenosis. STRESS and BENESTENT 1 pivotal clinical trials7,9 laid the foundations for approval and confirmation of the efficacy of coronary stents. These studies showed a reduction in the binary angiographic restenosis rates from 42.1% to 31.6% (p<0.05) and from 32% to 22% (p=0.02), respectively. The efficacy of coronary stents is due to the fact that these devices reduce the acute elastic recoil and late negative remodeling of coronary arteries because of their capacity to maintain the vessel adequately open without reducing vessel diameter.

Cronus® stent is fabricated in cobalt-chromium. This alloy is currently used cardiovascular stents and permanent implants in orthopedic (hips, knees), dental and maxillofacial surgeries. Guidant and Medtronic have conducted clinical evaluations of stents fabricated with a similar cobalt-chromium alloy and demonstrated safety and efficacy of the investigational devices. Both stents are currently available in the European market.

Study Design

Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Coronary Artery Disease

Intervention

Cronus® - Cobalt Chromium Coronary Stent (Angioplasty)

Location

Instituto de Cardiologia do Espírito Santo
Vitória
ES
Brazil
29040-091

Status

Not yet recruiting

Source

Scitech Produtos Medicos Ltda

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:04-0400

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