NCT01122719

Brazilian and Italian Evaluation of Safety Using Tacrolimus-eluting Stent With Short-term Dual Antiplatelet Regimen

The Best Trial - Brazilian and Italian Evaluation of Safety Using Tacrolimus-eluting Stent With Short-term Dual Antiplatelet Regimen

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: CID - Carbostent & Implantable Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of the Janus OPTIMA Tacrolimus-Eluting Stent (Optima TES, CID) for the treatment of de novo coronary lesions when associated with short-term (two months) dual antiplatelet (aspirin + clopidogrel) regimen.

Detailed description

The present study is a post-market, prospective, international, two-center, single arm study involving 60 patients with single, de novo non-complex coronary lesions. Enrolled patients will be asked to return for follow-up clinical evaluation at 1, 6, 12 and 24 months. At 3 months there will be an additional follow-up by phone contact. Furthermore, the first 15 patients should undergo angiographic and OCT follow-up at two months. The remaining 45 patients should undergo angiographic and IVUS follow-up at 8 months.

Conditions

• Stable Coronary Disease
• Unstable Coronary Disease
• Documented Silent Ischemia

Interventions

Type	Name	Description
DEVICE	Drug Eluting Stent

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-11-01
• Completion: 2013-03-01
• First posted: 2010-05-13
• Last updated: 2018-05-07

Locations

2 sites across 2 countries: Brazil, Italy