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.