Coronary Artery Disease Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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