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Sponsored by: |
International Biomedical Systems S.p.A. |
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Information provided by: | International Biomedical Systems S.p.A. |
ClinicalTrials.gov Identifier: | NCT00637104 |
The main objective of this study is to assess the safety and effectiveness of the TiN-coated MAR-Tyn stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to an uncoated control cobalt-chromium balloon-expandable stent (Vision, Abbott Vascular). Both stents are mounted on a Rapid Exchange Stent Delivery System.
Condition | Intervention | Phase |
---|---|---|
Coronary Artery Disease Angioplasty, Transluminal, Percutaneous Coronary Stents |
Device: Mar-Tyn TiN coated Co-Cr Numen stent implant Device: Vision Co-Cr stent implant |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A European Multicenter, Randomized, Single Blind Study of the MAR-Tyn Cobalt Chromium TiN-Coated Balloon-Expandable Stent in the Treatment of Patients With de Novo Coronary Artery Lesions |
Estimated Enrollment: | 160 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A - Mar-tyn: Experimental
It includes the implant of the Mar-tyn TiN coated stent
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Device: Mar-Tyn TiN coated Co-Cr Numen stent implant
Implant of the Mar-tyn TiN coated stent
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B - Vision: Active Comparator
Includes all the patients treated with the Vision stent
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Device: Vision Co-Cr stent implant
Implant of the Vision stent
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Occlusive coronary artery disease is predominantly caused by coronary atherosclerosis, a pathologic vascular condition characterized by abnormal lipid and fibrous tissue accumulation in the vessel wall. This condition may be accompanied by degenerative changes and/or calcification leading to stenosis (narrowing) of the luminal channel. Percutaneous Transluminal Coronary Angioplasty (PTCA) is a well-accepted method of non-surgical myocardial revascularization for selected patients with symptomatic occlusive coronary artery disease.
Restenosis is the most important challenge limiting the long-term success of coronary angioplasty. Symptomatic restenosis usually occurs 6 months after an angioplasty procedure. The rates of restenosis reported in numerous clinical trials vary from 13% to 57%. This variability may be attributed in part to differences in the methods used to assess the occurrence of restenosis and in the criteria used to define restenosis. Regardless of the exact percentage, restenosis remains the Achilles heel of angioplasty. Numerous pharmaceutical approaches to limit restenosis have been tested, but none have been successful to date.
It was chosen to coat the stent with Titanium Nitrate (TiN), which is an inert, biocompatible material, that creates a thin physical barrier to diffusion of toxic metal atoms, TiN creates a very smooth surface that is impossible to obtain with a metal alloy. This coating was applied to the cobalt chromium platform, "Numen", made of the L605 Cobalt-20 Chromium-15 Tungsten-10 Nickel alloy. This alloy contains the lowest Nickel percentage of Cobalt Chromium alloys used for surgical implants. The strut thickness of the platform is reduced to the minimum of 65 microns for optimal hemodynamic performance and to permit an ultra low profile delivery system. The "Numen" design complies with the requirements of the "LMS -Less Mismatch Stent" theory applied where multiple 1 mm high zigzags form the stent pattern to align the segments at 45° with respect to blood flow when the stent is expanded to its nominal diameter. TiN coating is being used commercially for their hard-wearing and chemical inactive properties, particularly for surgical tools. TiN features chemical stability, great hardness, excellent wear properties, low electric impedance, biocompatibility, hemocompatibility and the possibility, through the application process, to exchange the orientation of the grains, the hardness, the wear characteristics and also the biocompatibility (a nanocrystalline structure produces a chemical surface more suitable for the endothelial cells). The produced coatings were very fine grained and dense with a porosity within the film structure of less than 10 nm in diameter. Furthermore, in an iliac artery stent model in normal rabbits, safety and efficacy in reduced restenosis of the TiN coated Numen™ stent was assessed.
The special TiN coating of the Mar-Tyn stents is very promising in reducing the lesions and the causes of intima neoplasia.
This study is a multicenter (up to 8 European centers), prospective, randomized single blind study. This study has a 2-arm design assessing the safety and effectiveness of the Tin-coated MAR-Tyn stent to an uncoated control cobalt-chromium balloon-expandable stent (Vision, Abbott Vascular), both mounted on a Rapid Exchange Stent Delivery System. A total of 160 patients will be entered in the study and will be randomized on a 1:1 basis. Patients who meet the eligibility criteria will be either randomized to Treatment A or Treatment B. The patient will not know which stent will be implanted while the physician will be unblinded . Patients will be followed at 30 days, 6, and 12 months post-procedure, with all patients undergoing repeat angiography at 6 months. All adverse events up to the 1 year follow-up period will be collected and analyzed.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must meet ALL of the following criteria:
Exclusion Criteria:
Patients will be excluded if ANY of the following conditions apply:
Contact: Luigi Marras, Eng. PhD. | +39 3387795917 | luigi.marras@ibsmed.it |
Contact: Nader Shehata, Dr. Eng. | +39 040 3755 639 | Nader.shehata@ibsmed.it |
France | |
Département de Cardiologie - Hôpital Arnaud de Villeneuve | Not yet recruiting |
Montpellier, France | |
Contact: Piot jp-gagnol@chu-montpellier.fr | |
Principal Investigator: Christophe Piot, Prof. MD | |
Germany | |
Department of Internal Medicine III (Cardiology), University of Freiburg im Breisgau | Recruiting |
Freiburg im Breisgau, Germany, 79106 | |
Contact: Christoph Hehrlein, Prof. MD hehrlein@Medizin.Ukl.Uni-Freiburg.De | |
Principal Investigator: Christoph Hehrlein, Prof. MD | |
Italy | |
Campus Biomedico, Cardiologia | Recruiting |
Roma, Italy | |
Contact: Germano Di Sciascio, Dr. MD +39 06225411 g.disciascio@unicampus.it | |
Principal Investigator: Germano Di Sciascio, Dr. MD | |
Italy, BA | |
Policlinico Universitario di Bari-Emodinamica Interventista | Active, not recruiting |
Bari, BA, Italy | |
Italy, MI | |
Ospedale San Raffaele- Emodinamica e Cardiologia | Recruiting |
Milano, MI, Italy | |
Contact: Antonio Colombo, Dr. MD colombo.antonio@hsr.it | |
Principal Investigator: Antonio Colombo, Dr. MD | |
Italy, Ra | |
Ospedale di Ravenna, U.O. Cardiologia | Recruiting |
Ravenna, Ra, Italy | |
Contact: Marco Balducelli, Dr. MD +39 0544 285 388 ra.hocardioemo@ausl.ra.it | |
Principal Investigator: Marco Balducelli, Dr. MD | |
Netherlands | |
CARIM, Department of Cardiology | Not yet recruiting |
Maastricht, Netherlands | |
Contact: J. Waltenberger, Prof. MD j.waltenberger@cardio.azm.nl | |
Principal Investigator: J. Waltenberger, Prof. MD | |
Switzerland | |
Cardiocentro Ticino, Cardiologia | Active, not recruiting |
Lugano, Switzerland |
Principal Investigator: | Marco Balducelli, MD,FESC,FACC | Ospedale "S.Maria delle Croci" - Ravenna, Italy |
Responsible Party: | Head of Cardiology Department - S.Maria delle Croci Hospital, Ravenna (Italy) ( prof. Aleardo Maresta ) |
Study ID Numbers: | IBS/03-2007 |
Study First Received: | March 10, 2008 |
Last Updated: | September 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00637104 |
Health Authority: | Italy: Ministry of Health; Switzerland: Swissmedic; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices |
percutaneous transluminal coronary angioplasty stents restenosis biocompatible materials ceramics |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Chromium Cobalt |
Myocardial Ischemia Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Cardiovascular Diseases |