Assessment of the Numen Stent With Evaluation in a Randomized Study (ANSWERS)

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

Study Overview

• Status: Unknown
• Conditions: Lesion
• Intervention / Treatment: Device: PTCA with stent implantation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• France
  • Caen Cedex, France, 14033
    • Active, not recruiting
    • CHU côte de Nacre
  • Le Chesnay, France, 78150
    • Active, not recruiting
    • CMC De Parly II
  • Marseille, France, 13009
    • Active, not recruiting
    • Clinique Valmente
  • Marseille, France, 13012
    • Recruiting
    • Centre Hospitalier Privé Beauregard
    • Contact: Olivier Wittemberg; Phone Number: 0033491121090; Email: olwitt@aol.com
    • Principal Investigator: Olivier Wittemberg
  • Marseille Cedex 12, France, 13375
    • Active, not recruiting
    • Clinique Vert Coteau
  • Paris, France, 75006
    • Not yet recruiting
    • Clinique Turin
    • Principal Investigator: Thierry Corcos, MD, FACC
  • Paris, France, 75018
    • Active, not recruiting
    • Clinique Alleray-Labrouste
  • Tours Cedex, France, 37042
    • Active, not recruiting
    • Clinique Saint Gatien

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Numen	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.
ACTIVE_COMPARATOR: Vision/MiniVision	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cumulative incidence of Major Adverse Cardiac Events (MACE), Cerebrovascular Events CVE) and Major Bleedings (according to TIMI classification)	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Any death, cardiac death, stent related fatal / non fatal MI, TVR	1 month
Any death, cardiac death, stent related fatal / non fatal MI, TVR	6 months
Cardiac death, fatal/non fatal MI	In hospital
Procedural success, TLR, TVR, ST	In hospital

Collaborators and Investigators

• Sponsor: International Biomedical Systems S.p.A.
• Investigators: Principal Investigator: Thierry Corcos, MD, FACC, Clinique Turin, Paris, France

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (ANTICIPATED): September 1, 2009
• Study Completion (ANTICIPATED): September 1, 2009

Study Registration Dates

• First Submitted: November 12, 2008
• First Submitted That Met QC Criteria: November 12, 2008
• First Posted (ESTIMATE): November 13, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): February 17, 2009
• Last Update Submitted That Met QC Criteria: February 16, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: Treatment of de novo lesions in native coronary arteries
• Other Study ID Numbers: IBS/04-2007; 2008-A00111-54