Assessment of the Numen Stent With Evaluation in a Randomized Study (ANSWERS)
Recruitment status was Recruiting
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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 |
- 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 ]
- 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 |
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| Contact: Thierry Corcos, MD, FACC | +33-(0)1-40-088806 |
| 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 | |
| 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 May 16, 2013