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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by International Biomedical Systems S.p.A..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
International Biomedical Systems S.p.A.
ClinicalTrials.gov Identifier:
NCT00790283
First received: November 12, 2008
Last updated: February 16, 2009
Last verified: February 2009
  Purpose

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


Condition Intervention Phase
Lesion
Device: PTCA with stent implantation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Assessment of the Numen Stent With Evaluation in a Randomized Study

Further study details as provided by International Biomedical Systems S.p.A.:

Primary Outcome Measures:
  • Cumulative incidence of Major Adverse Cardiac Events (MACE), Cerebrovascular Events CVE) and Major Bleedings (according to TIMI classification) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Any death, cardiac death, stent related fatal / non fatal MI, TVR [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Any death, cardiac death, stent related fatal / non fatal MI, TVR [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Cardiac death, fatal/non fatal MI [ Time Frame: In hospital ] [ Designated as safety issue: No ]
  • Procedural success, TLR, TVR, ST [ Time Frame: In hospital ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: September 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790283

Contacts
Contact: Thierry Corcos, MD, FACC +33-(0)1-40-088806

Locations
France
CHU Cote de Nacre Active, not recruiting
Caen Cedex, France, 14033
CMC De Parly II Active, not recruiting
Le Chesnay, France, 78150
Clinique Valmente Active, not recruiting
Marseille, France, 13009
Centre Hospitalier Privé Beauregard Recruiting
Marseille, France, 13012
Contact: Olivier Wittemberg    0033491121090    olwitt@aol.com   
Principal Investigator: Olivier Wittemberg         
Clinique Vert Coteau Active, not recruiting
Marseille Cedex 12, France, 13375
Clinique Turin Not yet recruiting
Paris, France, 75006
Principal Investigator: Thierry Corcos, MD, FACC         
Clinique Alleray-Labrouste Active, not recruiting
Paris, France, 75018
Clinique Saint Gatien Active, not recruiting
Tours Cedex, France, 37042
Sponsors and Collaborators
International Biomedical Systems S.p.A.
Investigators
Principal Investigator: Thierry Corcos, MD, FACC Clinique Turin, Paris, France
  More Information

No publications provided

Responsible Party: Nader Shehata, International Biomedical Systems S.p.A.
ClinicalTrials.gov Identifier: NCT00790283     History of Changes
Other Study ID Numbers: IBS/04-2007, 2008-A00111-54
Study First Received: November 12, 2008
Last Updated: February 16, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by International Biomedical Systems S.p.A.:
Treatment of de novo lesions in native coronary arteries

ClinicalTrials.gov processed this record on August 28, 2014