To observe and evaluate the performance of a Sirolimus-eluting Drug-Coated Balloon (SCB) for the treatment of any type of coronary lesions, including native vessel disease and in-stent restenosis.
Prospective, multi-center, spontaneous clinical registry.
External validation of quality of data input, Centralised clinical event assessment.
Real world, all comers patients, consecutive enrollment.
2123 patients at 45 European/Asiatic sites.
Clinical follow up to 36 months.
Primary Endpoint:
Target Lesion Revascularization (TLR) at 12 months.
Secondary Endpoint:
MACE (Major Adverse Cardiac Events) as a composite of cardiac death, myocardial infarction (MI) and TLR at 6, 12, 24 and 36 months; any individual element of MACE;
Procedural success (defined as technical and angiographic success in the absence of MACE during hospitalization).
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Intellectual Property Rights
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Terms and Conditions
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Your use of the Website is at your own risk. Neither CMI nor any other party involved in creating, producing or delivering the Website is liable for any direct, incidental, consequential, indirect or punitive damages arising out of your access to, or use of, or browsing in the Website. This includes damages to, or arising out of viruses that may infect, your computer equipment or other property. Without limiting the foregoing, everything on the Website is provided to you “AS IS” Without warranty of any kind, either expressed or implied, including, but not limited to, the implied warranties of merchantability, fitness for a particular purpose or non-infringement. Please note that some jurisdictions may not allow the exclusion of implied warranties, so some of the above exclusions may not apply to you. Check your local laws for any restrictions or limitations regarding the exclusion of implied warranties.
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CMI reserves the right to alter or delete material from the Website at any time, and CMI may, at any time, revise these Terms and Conditions and the other Policies set forth in this Website by updating this posting. You are bound by any such revisions and should, therefore, periodically visit this page to review the then current Terms and Conditions and Policies.
Privacy policy
We do not collect any personally identifiable information about you unless you provide it to us voluntarily. If you do not want your personally identifiable information to be collected, please do not submit it to us.
If you do provide us with personally identifiable information, such as your name, postal address, e-mail address, telephone number and other personal information, we may contact you, via e-mail or regular mail to provide you with information we believe may be of interest to you. At the time, you will be offered the opportunity to opt out of this service. We do not sell or transfer to others outside our company the information you send to us, except that your data may be transferred to an outside fulfilment company for processing and mailing purposes only. We consider your e-mail address and any personal information you give to be private and these data will be kept confidential within CMI and by any outside Fulfilment Company. Within CMI, data may be transferred to or accessed by authorized CMI personnel in other countries. At all times, personal data are treated confidentially.
Data that are not personal, such as questions, comments, ideas and suggestions, shall be deemed to be non-confidential, and CMI shall be free to disclose and use the same, without any obligation whatsoever to you, for any purpose and through any means.
In addition, we may store some information on your computer to improve the quality of your visit to our Website. In some cases, this information will help us to tailor the content to your interests, or help us to avoid asking for the same information on repeat visits to the Website. With most Internet browsers, you can erase the information, referred to as “cookies” from your computer’s hard drive, block all cookies or even receive a warning before a cookie is placed on your system. Refer to your browser instructions or help button to learn more about cookies.
We are very concerned about protecting the privacy of children. We do not intend to collect any personally identifiable information from children under 18 years old. If a child has provided us with personally identifiable information, the parent or guardian of that child should contact us.
If at any time you do not wish us to contact you or if you have questions concerning our privacy practices, please feel free to reach out to us.
We are committed to protect the privacy and security of your personal data. We advise you to carefully read this Privacy Notice (“Notice”) so that you are aware of how, where, and why we are using your personal data.
INFORMATION WE MAY PROCESS (“Personal Data”)
We may collect personal data on this website, including information we collect while performing business transactions and information we collect from other sources, as permitted by law.
We may collect your personal data including but not limited to
MEANS OF PROCESSING DATA
We may process your Personal Data through the following means:
COOKIES
Cookies are alphanumeric identifiers with small amount of data that is commonly used as an anonymous unique identifier. These are sent to your browser from the website that you visit and are stored on your computer’s hard drive. Please note, a cookie in no way gives us access to your computer, that is to say, cookies cannot access any other information on your computer.
Our Website uses these cookies to collect information and to improve our Service by making your interaction with us faster and more secure. They may be used for the purposes of managing your preferences, maintaining and optimizing security, marketing, communication, analytics, and research.
We majorly use below types of cookies:
If you do not want to receive cookies, most browsers allow you to control cookies through their setting preferences. However, if you do turn off cookies in your browser, you will not be able to fully experience some of the features our Website.
GROUNDS FOR LAWFUL PROCESSING OF PERSONAL DATA
When we process your Personal data, we do so primarily in connection with marketing, sale, and promotion of services which we provide or which are procured using our services and to improve and enhance the range of those services and offerings. We may process your personal data for recruitment, communication, sales and marketing, registration and subscriptions purposes, where processing is necessary for the purpose of pursuing our legitimate interests.
USE OF PERSONAL DATA
We generally use the information to establish and enhance our relationship with our users for the following purposes:
We keep your personal data only for the duration of legitimate business requirements or as required by law.
TRANSFERRING YOUR PERSONAL DATA
As a global business, we may transfer your personal data to servers, entities and partners or other trusted third parties based in other countries so that they may process personal data on our behalf. By using our Website or otherwise providing us with your personal data, you agree to us doing so in accordance with the terms of this Privacy Notice and applicable data protection laws and regulations. We will take all steps reasonably necessary to ensure that your data is treated securely and in accordance our data protection policy, which is in line with applicable data protection legislation. We may also transfer your data to third party service providers and web analytics tool providers. CMI may permit certain third party companies to help CMI tailor the advertising that it thinks may be of interest to you, based on your use of our Website.
CHILDREN’S PRIVACY
We understand the importance of taking extra precautions to protect the privacy and safety of children using our Website. The Services are not intended for users under the age of 16. We do not knowingly collect any Personal data from children under 16 or market to or solicit information from anyone under the age of 16. If we become aware that a person submitting Personal data is under 16, we will delete all the information as soon as possible unless it is with the consent and involvement of a parent or guardian. If you believe we might have any information from or about a child under 16, please contact us at privacy@conceptmedicals.com.
SECURITY: HOW SECURE IS YOUR INFORMATION WITH US?
We have implemented appropriate physical, electronic, procedural and managerial procedures to safeguard your information against loss, unauthorized access, misuse or modification. We require any third parties processing your information to do the implement the same levels of protection with respect to your data. We strive to use commercially acceptable means for protecting your information.
CHANGES TO THE NOTICE
This Notice is effective as of {date}*. We reserve the right to update or change this Notice at any time, and we will provide you with the updated Notice when we make any substantial updates at the earliest either through email or by providing a prominent notice of change on the Website. You should check the Notice periodically. Your continued use of the Website after we post any modifications to the Notice on this page will constitute your acknowledgment of the modifications and your consent to abide and be bound by the modified Notice.
THIRD PARTY WEBSITES
From time to time we may provide links to the websites of other organisations, these links are provided for your information only. We have no control over the contents of those sites or resources, and accept no responsibility for them or for any loss or damage that may arise from your use of them.
Your rights and your personal data
We will respect your legal rights in relation to your data. Below are the rights granted to individuals located in the General Data Protection Regulation, and CMI is committed towards protection of the same.
We retain personal information for as long as we reasonably require it for legal or business purposes. In determining data retention periods, CMI takes into consideration local laws, contractual obligations, and the expectations and requirements of our customers. When we no longer need personal information, we securely delete or destroy it.