Clinical trial NCT00790283: Assessment of the Numen Stent With Evaluation in a Randomized Study
Official title: Assessment of the Numen Stent With Evaluation in a Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Lesion
Keywords: Treatment of de novo lesions in native coronary arteries
Lead sponsor: International Biomedical Systems S.p.A.
Sponsor class: INDUSTRY
First posted: 2008-11-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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)

Primary outcomes:
measure: Cumulative incidence of Major Adverse Cardiac Events (MACE), Cerebrovascular Events CVE) and Major Bleedings (according to TIMI classification)
timeFrame: 6 months
Secondary outcomes:
measure: Any death, cardiac death, stent related fatal / non fatal MI, TVR
timeFrame: 1 month
measure: Any death, cardiac death, stent related fatal / non fatal MI, TVR
timeFrame: 6 months
measure: Cardiac death, fatal/non fatal MI
timeFrame: In hospital
measure: Procedural success, TLR, TVR, ST
timeFrame: In hospital
Other outcomes:
Locations:
city: Caen Cedex
country: France
facility: CHU Cote de Nacre
city: Le Chesnay
country: France
facility: CMC De Parly II
city: Marseille Cedex 12
country: France
facility: Clinique Vert Coteau
city: Marseille
country: France
facility: Clinique Valmente
city: Marseille
country: France
facility: Centre Hospitalier Privé Beauregard
city: Paris
country: France
facility: Clinique Turin
city: Paris
country: France
facility: Clinique Alleray-Labrouste
city: Tours Cedex
country: France
facility: Clinique Saint Gatien
Study officials:
affiliation: Clinique Turin, Paris, France
name: Thierry Corcos, MD, FACC
role: PRINCIPAL_INVESTIGATOR
References: