Information for the patient

Main information

Clinical study on "Disorders of haemodynamic parameters and tissue biochemistry in patients with multiple sclerosis coexisting with chronic cerebrospinal venous insufficiency. (CCSVI vs.SM)".

Venous constriction angioplasty is not a standard treatment procedure in CCSVI. Such a procedure may result in temporary or permanent improvement of the clinical condition, but there is also a risk of its worsening.

There is no sufficient, conclusive and fully reliable scientific evidence to indicate its effectiveness or ineffectiveness, in particular in relation to the symptoms of multiple sclerosis.

This procedure will be carried out in the context of a clinical trial and is intended to collect relevant scientific data that may determine the effectiveness or ineffectiveness of this proceeding in selected clinical situations.

The risk of procedure and complications

Every medical procedure carries the risk of complications. The degree of risk consists of many factors, such as: the severity of the disease, the patient's state of health, the coexistence of other diseases, etc. Therefore, some of them cannot be predicted.

The operator and the whole team will perform their work, with reasonable care, to safely carry out the planned procedure.

Although complications are rare, the most common are: Pain at the vascular access point; haematoma at the vascular access point; pseudoaneurysm at the vascular access point; allergic reaction to contrast; transient cardiac rhythm disturbances during surgery.

Extremely rare but serious complications include: Vascular damage of a large calibre vessel, thrombosis within a large calibre vessel; Heart rhythm arrythmia arising during and persisting after surgery and requiring specialist treatment; damage to heart structures; intracranial hematoma; abdominal hematoma inside the chest; anaphylactic shock; Infection at the vascular access point; or systemic infection; Unplanned leaving of the tool in the vascular system due to its dysfunction; Risk of systemic complications.

Extremely rare as a consequence or independently of the procedure, systemic complications such as pneumonia, deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke or death may occur.

Other legal information

Please note that the lead researcher, sponsor, relevant Bioethics Committee or regulatory authority have the right to terminate the trial for medical or non-medical reasons at any time, without the patient's consent.

In the event of side effects and injuries arising from participation in the trial, the hospital will immediately provide the patient with the necessary care and treatment and, if necessary, enable further medical care. The lead researcher and sponsor have obtained insurance to cover the costs of treatment of side-effects and injuries arising from participation in the trial. Liability of the sponsor of the clinical trial and the lead researcher, in accordance with the applicable regulations, has been covered by the Compulsory Civil Liability Insurance Policy of Researcher and Sponsor , Certificate number 000-17-447-05935266 issued by Piotr Okrasa of the TUiK Allianz Polska S.A. based in Warsaw at ul. Rodzin Hiszpańskich 1 and under conditions applicable to it. In accordance with the applicable regulations, civil liability insurance covers the liability of the researcher and the sponsor for causing physical injury, disorder of health or death of the research participant as a result of the act of omission of the insured person or people for whom they are responsible, during the period of insurance cover, caused in connection with the conduct of the research. The patient may also make a claim for compensation directly to the insurer. The amount of compensation will be determined in accordance with Polish civil law.

The lead doctor has a copy of the insurance certificate that can be reviewed by you at any time.

What are the benefits of participating in the research?

There is no guarantee that the patient will get any benefits from participating in the research. However, the results of this study may contribute to the development of a new treatment method for that patient and other people suffering from abnormal venous outflow from the CNS coexisting with MS.

Privacy policy

CCSVI Clinic Ltd with its registered office in Warsaw ul. Walbrzyska 11/252 is the administrator of your personal data. Detailed data will be processed in accordance with Regulation (EU) 2016/679 of the European Parliament and the Council from 27th April 2016 on the protection of individuals with regard to the processing of personal data and on the free transfer of such data and the repeal of Directive 95/46/EC.

Personal data is collected within the framework of the use of our service in order to guarantee a more secure service, improve the quality of our services, adjust our services to your needs, and create a service that you will be happy to use.

Your personal data will be processed:

  1. to provide services by electronic means and to conclude sales contracts,
  2. to direct marketing content in the manner to which consent has been given,
  3. for the purpose of meeting legal obligations under generally applicable laws,
  4. for the purpose of analysis and statistics,
  5. in order to pursue the legitimate interest of the Company.

In accordance with the law, we may transfer your data entities processing them on our behalf, i.e. subcontractors of our services, marketing agencies and other entities entitled to obtain data on the basis of applicable law, e.g. courts or law enforcement agencies - of course only if they make a request based on the relevant legal basis.

You have the right to request access to your personal data, the right to rectify, delete or restrict the processing of your data. You may object, withdraw your consent to the processing of your data at any time. To do so, please contact us via the contact form or by sending an email to info@ccsvi-clinic.com.

Providing personal data is voluntary, however, it is necessary in order to provide services by electronic means or to conclude and perform sales contracts. The consequence of not providing the required personal data is that services cannot be provided by electronic means or sales contracts cannot be concluded.

Any processing of your data must have a legal basis in accordance with applicable law. The legal basis for the processing of your data for the purpose of providing services, including their adjustment to your needs, interests, analysing and improving them and ensuring their safety is the need for agreements for their provision (these agreements are usually regulations).

The legal basis for the processing of personal data for the purpose of statistics and self-marketing of administrators is the so-called legitimate interest of the administrator. The processing of your data for marketing purposes carried out by CCSVI Clinic on behalf of Trusted Partners and directly by Trusted Partners will take place on the basis of your voluntary consent.

Your data will be processed until the duration of the basis for their processing, i.e. from the moment of giving your consent to its withdrawal or other actions on your part which will limit this consent, in case of necessity of the personal data to perform the contract, for the duration of its performance and possibly the statute of limitations (usually no more than 3 years, and a maximum of 6 years). If the data processing is based on a legitimate interest of the administrator, until you raise an objection.

The Company will not transfer personal data to third countries.

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