NCT01093391

A Trial of Bare Metal Stent - Cobalt Chromium Versus Stent Coating With Sirolimus

A Randomized Trial of Bare Metal Stent (Cronus®) - Cobalt Chromium Versus Stent Coating With Sirolimus (DES)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Scitech Produtos Medicos SA · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to evaluate the security issues and efficacy of coronary stenting Cobalt Chrome covered with sirolimus-eluting Cobalt Chrome platform in patients with coronary artery lesion.

Detailed description

Patients will be treated in compliance with the eligibility criteria, with stent study of 16-19mm. All patients are clinically followed for 60 months after the procedure and will undergo a control angiography 6 months. Can be treated multiple lesions, measuring between 2.5-3.5mm (by visual estimate). Patients enrolled will be randomized in a 1:2 propose in one of the groups with or without stent coating, respectively. And a randomized clinical trial, prospective study in 5 centers including 60 patients.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	DRUG ELUTING STENT	Site preparation and percutaneous access should be performed as per standard hospital procedures.It is recommended to cross the target lesion with 0.014-inch exchange-length guide wire. The involved lesion should be predilated with appropriately sized balloons using standard techniques. It is strongly encouraged that the Investigators use similar materials and techniques throughout the study to maintain consistency and standardization of care.A stent consists of an endovascular prosthesis with a metallic mesh structure that is implanted at the site of the artery blockage via catheterization procedure. The objective of stenting is to obtain an angiographic appearance of the expanded stent only outside the limits of the target vessel filled with contrast medium.
DEVICE	BARE METAL STENT	Site preparation and percutaneous access should be performed as per standard hospital procedures.It is recommended to cross the target lesion with 0.014-inch exchange-length guide wire. The involved lesion should be predilated with appropriately sized balloons using standard techniques. It is strongly encouraged that the Investigators use similar materials and techniques throughout the study to maintain consistency and standardization of care.A stent consists of an endovascular prosthesis with a metallic mesh structure that is implanted at the site of the artery blockage via catheterization procedure. The objective of stenting is to obtain an angiographic appearance of the expanded stent only outside the limits of the target vessel filled with contrast medium.

Timeline

• Start date: 2010-11-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2010-03-25
• Last updated: 2015-07-22

Locations

4 sites across 1 country: Brazil