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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


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
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