Status:
UNKNOWN
Assessment of the Numen Stent With Evaluation in a Randomized Study
Lead Sponsor:
International Biomedical Systems S.p.A.
Conditions:
Lesion
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 an...
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...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Clinical or instrumental documentation of stable/unstable myocardial ischemia or angina with a \>50% lesion on a major coronary vessel and/or side branch \> 2.0 mm
- Lesion length ≤ 20 mm
- Vessel requiring stent size with diameter ≥ 2.5 mm
Exclusion
- Age \< 18 years
- Life expectancy \< 6 months
- Chronic renal failure (serum creatinine \> 2 mg %)
- Ongoing acute myocardial infarction
- Left ventricular ejection fraction (LVEF) \<30%
- Cardiogenic shock
- Documented or suspected systemic and/or infectious disease
- Hypersensitivity to cobalt chromium or contrast media
- Anti-thrombotic drug intolerance
- Cardiac and/or extracardiac documented disease requiring surgical repair
- Patient is not an acceptable candidate for emergent coronary artery bypass surgery
- Primary or secondary pulmonary hypertension (by echo-doppler)
- Planned \> 2 stent implantation (except bail-out)
- Recent (\< 6 months) PCI or CABG
- Other type of stent implantation (also in case of bail-out)
- Visible endocoronary thrombosis
- Diffuse, severe coronary calcifications
- Use of debulking devices
- Extreme vessel tortuosity
- Unprotected left main stenosis (ULM)
- Bifurcation lesion
- In stent restenosis (ISR)
- Saphenous vein graft (SVG) and arterial by pass (internal mammary artery,IMA)
- Chronic total occlusion (CTO)
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00790283
Start Date
September 1 2008
End Date
September 1 2009
Last Update
February 17 2009
Active Locations (8)
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1
CHU Cote de Nacre
Caen, France, 14033
2
CMC De Parly II
Le Chesnay, France, 78150
3
Clinique Valmente
Marseille, France, 13009
4
Centre Hospitalier Privé Beauregard
Marseille, France, 13012