I will repeat this: chronic fatigue is one of the more disabling symptoms in multiple sclerosis. Following balloon angioplasty, we found significant improvements in this symptom. This is particularly interesting, because until now there have not been effective treatments for chronic fatigue, and chronic fatigue is really disabling for multiple sclerosis patients and is completely orphaned from any effective treatment today.
It is clear that more study is needed, but treatment must not wait for clinical trials. Actually, in Italy, we are starting randomized controlled trials, but I think that this kind of treatment is completely proposable under the umbrella of the ethical committee measuring what exactly happened in the follow-up of patients who undergo this treatment.
We also performed another randomized control study in cooperation with the State University of New York at Buffalo by comparing two groups of patients. In one, the early treatment group, the angioplasty was performed at a baseline. In the second group of patients, angioplasty was delayed for six months. This study demonstrated that balloon angioplasty is safe and well tolerated, thus confirming the safety of this kind of treatment. The rate of restenosis was 29% in the damaged jugular vein, but zero per cent in the azygous vein. Very importantly, we found a significant decrease in the number of T2 lesions blindly measured by the means of MRI, and this also confirmed that this kind of treatment is protective for multiple sclerosis patients.
My conclusions are that CCSVI exists and is a serious obstruction, a major vascular problem, whether a patient has multiple sclerosis or not. CCSVI is significantly related to multiple sclerosis patients at different latitudes and of different genetic background populations. Angioplasty corrects the blood flow from the brain and, really, the correction helps people with multiple sclerosis.
I think it is irresponsible not to proceed with angioplasty treatment of CCSVI in patients with multiple sclerosis under the umbrella of controlled studies, supervised by ethical committees in tertiary hospitals, and with all the capability in interventional radiology and in vascular and endovascular surgery.
Thank you.