Assessment of the Numen Stent With Evaluation in a Randomized Study

Lesion Clinical Trial

— ANSWERS  

Official title:

Assessment of the Numen Stent With Evaluation in a Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00790283
• Other study ID #: IBS/04-2007
• Secondary ID: 2008-A00111-54
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: November 12, 2008
• Last updated: February 16, 2009
• Start date: September 2008
• Est. completion date: September 2009

Study information

• Verified date: February 2009
• Source: International Biomedical Systems S.p.A.
• Contact: Thierry Corcos, MD, FACC
• Phone: +33-(0)1-40-088806
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lesion

Intervention

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.

Locations

Country	Name	City	State
France	CHU Cote de Nacre	Caen Cedex
France	CMC De Parly II	Le Chesnay
France	Centre Hospitalier Privé Beauregard	Marseille
France	Clinique Valmente	Marseille
France	Clinique Vert Coteau	Marseille Cedex 12
France	Clinique Alleray-Labrouste	Paris
France	Clinique Turin	Paris
France	Clinique Saint Gatien	Tours Cedex

Sponsors (1)

Lead Sponsor	Collaborator
International Biomedical Systems S.p.A.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of Major Adverse Cardiac Events (MACE), Cerebrovascular Events CVE) and Major Bleedings (according to TIMI classification)		6 months	No
Secondary	Any death, cardiac death, stent related fatal / non fatal MI, TVR		1 month	No
Secondary	Any death, cardiac death, stent related fatal / non fatal MI, TVR		6 months	No
Secondary	Cardiac death, fatal/non fatal MI		In hospital	No
Secondary	Procedural success, TLR, TVR, ST		In hospital	No