NCT00790283

Assessment of the Numen Stent With Evaluation in a Randomized Study

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: International Biomedical Systems S.p.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to Evaluate the Short-Term and Mid-Term Safety and Efficacy of the NUMEN Cobalt-Chromium coronary stent for the treatment of de novo lesions in native coronary arteries and compare it to the VISION/MINIVISION coronary stent

Detailed description

The success of bare metal coronary stenting is limited by the restenosis phenomenon, with rates depending on patient vascular morphology and lesion-related factors, the indication for and technique of stent deployment, and others. Drug-eluting stents (DES) improve the treatment of many coronary artery lesions by significantly reducing in-stent restenosis. However, there have numerous limitations resulting from the need for long-term dual antiplatelet therapy, the consequent bleeding risk (old patients, surgery, colon or gastric cancer, trauma), the unknown side-effects of long-term antiplatelet therapy, the cost associated with a long-term thienopyridine regimen, the body's reaction to the stent polymer, and the 0.2% per year increase in late stent thrombosis in comparison with bare metal stents (BMS). For these reasons, continuous research is devoted to improve the effectiveness of bare metal stents. The ideal stent should be non-thrombogenic, with a low rate of restenosis and late thrombotic events. The NUMEN stent has been designed to meet these criteria, using an extremely low stent strut thickness.

Conditions

• Lesion

Interventions

Type	Name	Description
DEVICE	PTCA with stent implantation	Eligible patients will be randomly assigned to the implantation of one (or more) Numen or Vision/Mini Vision stent. Each patient will undergo a 1-month follow-up and a clinical visit at 6 months from the procedure.

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2008-11-13
• Last updated: 2009-02-17

Locations

8 sites across 1 country: France