NCT01090609

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

Multicenter, Prospective, Non-randomized Study to Evaluate the Safety of Cronus® Cobalt Chromium Coronary Stent - Study After 9 Months

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 263 (actual)
• Sponsor: Scitech Produtos Medicos SA · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Stent implantation	Stent implantation

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-09-01
• Completion: 2014-11-01
• First posted: 2010-03-22
• Last updated: 2014-11-14

Locations

13 sites across 1 country: Brazil