A Phase 2/3 interventional study of PTCA with stent implantation in Lesion, sponsored by International Biomedical Systems S.p.A.. Status unknown at 8 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-02-17.
Sponsored by International Biomedical Systems S.p.A. · Phase 2/3, Interventional, and Treatment
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
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.
International Biomedical Systems S.p.A. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: PTCA with stent implantation
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.
Cumulative incidence of Major Adverse Cardiac Events (MACE), Cerebrovascular Events CVE) and Major Bleedings (according to TIMI classification)
Time frame: 6 months
Any death, cardiac death, stent related fatal / non fatal MI, TVR
Time frame: 1 month
Any death, cardiac death, stent related fatal / non fatal MI, TVR
Time frame: 6 months
Cardiac death, fatal/non fatal MI
Time frame: In hospital
Procedural success, TLR, TVR, ST
Time frame: In hospital
This study is status unknown, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.
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International Biomedical Systems S.p.A.