open label randomized clinical trial that will enroll 150 patients in 10
centers in India. The primary endpoint is 9-month in-stent late loss within
the stented segment post-procedure and historical comparison with 6 to
9-month in-stent late loss with other drug-eluting stents. The secondary
endpoints include Angiographic Binary Restenosis, Target Lesion
Revascularization (TLR), Target Vessel Revascularization (TVR) and Target
Vessel Failure (TVF) rates at nine months, Major Adverse Cardiac Events
(MACE), acute, sub-acute and late Stent thrombosis at 30 days and 9 and 12
months, Lesion, Device as well as Procedure success. The Principal
Investigator of the study is Dr. Balram Barghava MD. of All India Institute
of Medical Sciences, New Delhi, India.
Relisys' new Corel + C drug-eluting stent comprises a Cobalt-Chromium
Stent that is coated with a macro-porous nano-structured carbon-composite
matrix containing the active drug paclitaxel. The coating has been
developed and provided by CINVENTION, the Germany based company specialized
in nano- composite materials and surface engineering. The coating
eliminates the use of polymers and provides a bioactive coating with less
thrombogeneity and pro- endothelialization surface design - thus,
completely reducing tissue inflammation and reaction, but additionally
enhancing engraftment and endothelialisation.
Dr. Balram Bhargava, the principal investigator, explained that he
expects significant improvements in the short, mid and long-term clinical
outcomes. "This is the first time that a nano-structured coating is used as
an elution platform. The coating itself is made out of non-thrombogenic
glassy carbon, the bio-availability of paclitaxel is nearly hundred percent
and, additionally, the surface structure of the coating promotes
endothelial cell attachment and proliferation. We are confident that this
trial will show excellent results and demonstrate that the non-polymeric
bioactive nano- composite coating will reduce the late thrombosis issue
significantly," said Dr. Balram Bhargava.
The enrolment of the study will be carried out throughout 10 clinical
trial centers in Bangalore, Ahmadabad, Vellore, Bangalore, Chandigarh,
Hyderabad, New Delhi and Mumbai. Dr. Soheil Asgari, Chief Executive Officer
and Chief Technology Officer of CINVENTION, pointed out, that the enrolment
will be finished within 4 weeks. "The investigators community has access to
a large collective of patients and we expect the stenting of the patients
within four to five weeks." He also referred to previous pre-clinical data
that showed excellent histomorphometric and histopathology data indicating
the non- inflammatory and pro-healing properties of the coating. "The
CINVENTION coating replaces inflammatory polymers - either durable or
absorbable - by the most inert material known, i.e. carbon. CINVENTION's
technology enables the embedding of drug control properties together with a
surface design that attracts endothelial cells and allows attachment and
proliferation on the nano-structured surface". Furthermore, he said that
CINVENTION has created significant knowledge in surface design for tissue
engineering and mammalian cell cultivation. This knowledge was transferred
to the nano-structured design of the carbon-coating material.
Badari Narayan, Managing Director of Relisys Medical, stated that he
expects a clear result demonstrating the superior performance of the Corel
+ C stent. "The Corel+ C stent has unique advantages. While other companies
are still in the early development phase of non-polymeric stents, Relisys
has gained a head start over the community. We combine the advantages of a
Cobalt Chromium stent with an excellent profile and deliverability together
with the proven drug paclitaxel and the most advanced coating platform. The
Corel + C stent was specifically designed to eliminate the potential
complications of thrombosis that are now identified as the main issues of
Drug-Eluting Stents."
The animal trials for the advanced Corel + C drug-eluting stent were
completed at the Cardiovascular Research Institute, Washington D.C., and
published in April 2006. The animal data have shown the safety and efficacy
of the Corel + C drug-eluting stent, including its innovative porous
carbon/carbon composite coating technology.
CINVENTION AG
CINVENTION AG is a leading technology company focusing on
nano-composite materials in biomedical applications (learn more about
CINVENTION at cinvention/.
CINVENTION's unique portfolio of Nano-Composite Systems includes: Drug
Delivery Coatings, Multifunctional Device Coatings, Advanced Cultivation
Systems for Bio-Processing and Systems for Tissue Engineering.
CINVENTION's mission is to exploit its proprietary and highly
innovative technology platform for materials and surface engineering of
nano-structured composites. Providing a sustainable portfolio of
applications in medical device engineering, bio-processing and chemical
processing CINVENTION solutions enable its customers to acquire superior
technologies for next generation applications.
Relisys Medical Devices
Relisys Medical Devices Limited is a leading Indian medical device
manufacturer, which has taken a lead in the indigenous development of
medical devices like coronary stents, catheters and critical care products
in India.
Relisys focus products includes: Drug-eluting stents,
Angiographic/Angioplasty catheters, Occlusive devices, Cardiac surgery
disposables and Critical care products.
Relisys Medical Devices mission is to make quality medical care
affordable through development of cutting edge technology and competitive
pricing. Relisys Manufacturing facilities include a stent coating division
and an integrated catheter manufacturing facility with in-house
compounding, extrusion, injection molding, braiding, welding, tipping,
grinding, sterilization and others.
Cinvention AG
cinvention/
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