CCSVI, or chronic cerebrospinal venous insufficiency, is a clinical and haemodynamic hypothesis concerning venous drainage from the brain and spinal cord. This page reviews Dr Ciro Gargano’s experience in vascular diagnostics and angioplasty of the jugular and azygos veins, while also explaining what research has clarified in subsequent years.
An important clarification
CCSVI has been the subject of extensive scientific debate, particularly over its possible association with multiple sclerosis. Clinical experiences and individual patient testimonials form part of this research history, but they do not independently demonstrate treatment effectiveness. Venous angioplasty is not a cure for multiple sclerosis and does not replace neurological assessment or prescribed treatments.
On this page
What is CCSVI?
The acronym CCSVI stands for Chronic Cerebrospinal Venous Insufficiency. Professor Paolo Zamboni proposed this term to describe a condition in which abnormalities of the main extracranial venous pathways might hinder blood returning from the central nervous system to the heart.
The most extensively studied veins are the internal jugular veins, which drain a substantial proportion of blood from the brain, and the azygos vein, located in the chest and also connected with venous drainage of the spinal cord. Described abnormalities include dysplastic or poorly mobile valves, intraluminal membranes and septa, circular narrowings, hypoplastic venous segments and other anatomical or functional changes.
The main scientific debate concerns not only the existence of individual venous abnormalities, which can be documented, but their clinical significance: how much they affect drainage, how common they are in healthy people or those with other illnesses, and what relationship, if any, they have with neurological symptoms.
Jugular veins, the azygos vein and possible outflow abnormalities
Venous flow depends on body position, breathing, pressure changes in the chest and the availability of alternative venous pathways. Assessing cerebrospinal drainage is therefore more complex than simply measuring a vein’s diameter.
- Valve abnormalities: thickened, stiff or incorrectly orientated leaflets, or reduced leaflet mobility.
- Septa and membranes: intraluminal structures that may interfere with blood flow.
- Stenosis or annulus: focal or circular narrowing of the venous lumen.
- Hypoplasia: underdevelopment of a segment of vein.
- Twisting or compression: changes in the course or diameter that may vary with posture.
- Extrinsic compression: structures outside the vein may sometimes compress it. Described muscular causes include anatomical variants or hypertrophy of the omohyoid muscle, which can compress the internal jugular vein (further information on PubMed).
- Agenesis: failure of a venous segment to develop, with possible compensation through alternative venous pathways.
The presence of one of these features does not automatically establish it as the cause of a neurological symptom. Anatomy, haemodynamics, symptoms and differential diagnosis should be considered separately.
The 2009 IUP consensus and truncular venous malformations
In September 2009, an international panel of the IUP, International Union of Phlebology, unanimously recommended the Hamburg classification for venous malformations. The document classified stenotic lesions of the main extracranial venous pathways, including the jugular veins, superior caval system and azygos vein, as congenital truncular venous malformations.
It is therefore correct to recall that the consensus document recognised and classified these types of venous abnormalities. However, it is more accurate not to interpret that step as definitive endorsement of the entire CCSVI theory or its treatment in multiple sclerosis: these aspects were assessed by later studies and remain conceptually distinct.
Read the IUP consensus document indexed in PubMed.
The colour Doppler ultrasound protocol proposed by Professor Zamboni
The original protocol used venous colour Doppler ultrasound with a specific method, in supine and seated positions, to look for five haemodynamic criteria:
- reflux in the internal jugular and/or vertebral veins in different positions;
- reflux in the deep cerebral veins;
- ultrasound evidence of abnormalities or narrowing of the internal jugular veins;
- absence of detectable flow in the internal jugular and/or vertebral veins;
- abnormal postural control of cerebral venous outflow.
Under Zamboni’s proposal, the presence of at least two of the five criteria allowed the examination to be classified as positive for CCSVI. Dr Gargano trained in this protocol and applied it in the historical diagnostic pathway for his patients.
Later studies identified problems with reproducibility between operators and centres. Colour Doppler ultrasound is a dynamic, operator-dependent examination: technique, position, breathing and interpretative criteria can affect results. The five criteria should therefore be presented as part of the historical research protocol, rather than as a universally accepted diagnostic standard today.
Further information on inter-operator reproducibility of the Doppler protocol.
What venous angioplasty involves
Venous angioplasty for CCSVI is an endovascular procedure. A catheter is introduced through venous access, usually femoral, and venography is performed to examine the relevant veins. If a narrowing is identified, a balloon is positioned in the target segment and inflated to widen the lumen.
During the period documented on the former website, Dr Gargano’s protocol included colour Doppler checks before, during and after the procedure, followed by scheduled clinical reassessment. The historical approach was to use a balloon without implanting stents in the jugular veins, given the lack of dedicated venous devices and the potential risks of an implant in that location.
Like all invasive procedures, venoplasty may cause complications. Indications, expected benefits, alternatives and risks should be assessed using the available evidence and current clinical recommendations.
Dr Ciro Gargano’s training and experience
CCSVI represented an important part of the professional and scientific work of Dr Ciro Gargano. In the 2010/2011 academic year, at the University of Ferrara he completed the second-level university Master’s degree in Haemodynamics and Advanced Venous Surgery, worth 60 academic credits, passing the final examination on 20 October 2011.
Successful completion of the examination was certified by the University of Ferrara Vascular Diseases Centre in a statement signed by Professor Paolo Zamboni as Director of the Centre. After this training, Dr Gargano managed a personal case series of more than 1,500 procedures on the jugular and azygos veins.
The work was not limited to the technical performance of angioplasty. The pathway was organised with other professionals and included vascular, neurological and neuropsychological assessment, ultrasound checks and follow-up. The aim was to observe possible clinical changes systematically rather than rely solely on the patient’s immediate impression.
The multidisciplinary protocol and neuropsychological assessment
The historical protocol documented by the centre included assessments before the procedure, checks during and immediately afterwards, and later reassessment. Depending on clinical needs, the neuropsychological battery included:
- Selective Reminding Test;
- 10/36 Spatial Recall Test;
- Symbol Digit Modalities Test;
- Paced Auditory Serial Addition Test (PASAT);
- delayed recall tests;
- Word List Generation.
Questionnaires on mood, quality of life and disease impact were also used, including BDI-II, PHQ-9, MSQOL-54 and MSIS-29; CAREQOL-MS was included for caregivers. The value of this documentation lies particularly in its use of repeatable measures of cognitive function and quality of life.
The observational study: 53 patients and six-month follow-up
In March 2011, Dr Gargano began the ‘Non-profit observational study assessing EDSS (Expanded Disability Status Score) in patients with multiple sclerosis and chronic cerebrospinal venous insufficiency (CCSVI) treated with percutaneous angioplasty’. The retained accompanying documentation records the project’s opinion no. 2/r.p.s.o of 16 March 2011 and authorisation decision no. 8 of 21 March 2011. The protocol initially planned for 40 participants; between April and June 2011, 53 patients meeting the specified criteria were actually enrolled.
Assessments took place before the procedure, after 30 days and after six months. The primary outcome was EDSS; depression, multiple sclerosis impact and quality of life were also measured using BDI, MSIS-29, EQ-5D and EQ-5D VAS. Mean age was 42.4 years and mean disease duration 11.9 years; 37.7% had relapsing-remitting disease, 54.7% secondary progressive disease and 7.6% primary progressive disease.
Observed EDSS values
| Assessment | Mean EDSS | Patients assessed | Comparison with baseline |
|---|---|---|---|
| Before the procedure | 5,4 ± 2,1 | 53 | Baseline |
| After 30 days | 4,8 ± 2,3 | 53 | p < 0,001 |
| After 180 days | 4,5 ± 2,4 | 44 | p < 0,001 |
In the final report, patients with a reduced EDSS were classified as ‘responders’, while those with stable or increased EDSS were classified as ‘non-responders’. Under this definition, the report gave a responder proportion of 64,2% (95% confidence interval: 50.7%–75.7%).
BDI, MSIS-29, EQ-5D and EQ-5D VAS showed a mean improvement at 30 days in both groups. At six months, improvement remained statistically significant only in the responder group. The report itself interpreted the early improvement common to both groups as consistent with a possible short-term placebo effect.
Reported adverse events
The document recorded two haematomas of the venous wall, corresponding to 3.8%, resolving in approximately two weeks; one venous thrombosis, 1.9%; and one venous restenosis, 1.9%. The authors noted that the sample was too small to estimate the incidence of relatively rare events reliably.
How the results should be interpreted
The report explicitly concluded that, because of the observational design, a cause-and-effect relationship could not be established between angioplasty and improvement in clinical conditions related to multiple sclerosis. There was no randomisation or control group, and participant numbers were limited, particularly for subgroup and safety analyses.
The study’s value therefore lies in prospectively documenting a real-world case series using standardised scales, predefined follow-up times and adverse-event recording. The results were an observational signal requiring further investigation and should now be considered alongside subsequently published controlled studies.
Patient-reported improvements and their meaning
Over the years, many patients reported changes in fatigue, walking, sensation, sleep quality, temperature regulation or bladder function. Some of these experiences are preserved in an extensive video archive recorded after the procedures.
These testimonials are important as records of individual experiences and as sources of research questions. However, they are not proof of effectiveness: they lack a control group, may be affected by case selection and cannot predict another person’s outcome. The duration of a reported improvement may also vary considerably.
View the historical archive on the YouTube channel.
CCSVI and multiple sclerosis: what studies show today
To interpret the literature correctly, three questions should be distinguished: whether particular venous abnormalities are more common in people with multiple sclerosis; whether they have a causal role in the disease; and whether correcting them through angioplasty produces a reliable clinical benefit.
Association
A meta-analysis published in 2023 in BMJ Open, including 20 studies and 3,069 participants, found a higher frequency of CCSVI in multiple sclerosis groups than in healthy controls. The pooled estimate was OR 3.36, with substantial heterogeneity between studies (I² 79%). This suggests a statistical association but does not establish CCSVI as the cause of multiple sclerosis.
Read the meta-analysis published in BMJ Open.
Effectiveness of angioplasty
The randomised controlled BRAVE DREAMS trial did not demonstrate an overall clinical benefit of venoplasty on the functional outcomes assessed and concluded that the procedure could not be recommended for treating multiple sclerosis. A later expanded analysis discussed possible radiological signals and differences related to venous morphology, but it did not change the general clinical recommendations.
The available Cochrane review found no benefit on major patient-centred outcomes, including disability, relapses, quality of life and physical or cognitive function. The currently published NICE guidance states that venoplasty for CCSVI should not be used in managing multiple sclerosis, given the lack of demonstrated benefit and possible complications.
- Cochrane review of venoplasty for CCSVI in multiple sclerosis
- Currently published NICE recommendations
The relationship with neurological treatment
There is currently no treatment that guarantees a permanent cure for multiple sclerosis. However, disease-modifying treatments can reduce inflammatory activity, relapses and, in many cases, the risk of progression. The choice depends on disease type and activity and should be agreed with the neurologist.
Vascular assessment should not lead patients to stop or change prescribed medicines on their own. This principle was already included in the FAQs on Dr Gargano’s former website and remains essential.
AISM information about multiple sclerosis therapies and treatments.
Professional experience worth documenting
The CCSVI debate was intense and often polarised. Documenting this experience today does not mean ignoring later studies or dismissing observations from clinical practice. It means preserving an important part of Dr Gargano’s professional history, making protocols and materials accessible, and helping readers distinguish hypotheses, observations, testimonials, controlled studies and recommendations.
The historical archive includes television and press interviews, scientific documents, clinical cases and numerous video testimonials. Content will be selected and republished gradually with the necessary context, avoiding technically outdated material or items without adequate documentation.
Frequently asked questions about CCSVI
What is CCSVI?
It is the proposed name for a condition involving anatomical or haemodynamic abnormalities in the main venous pathways draining the brain and spinal cord. Its clinical significance and relationship with neurological diseases have been researched and debated.
Which veins are involved?
The most studied are the internal jugular veins and the azygos vein. Vertebral veins and alternative venous pathways involved in cerebrospinal drainage may also be assessed.
How was it diagnosed under the Zamboni protocol?
Using a specific colour Doppler ultrasound examination performed in supine and seated positions. The protocol sought five haemodynamic criteria and defined the examination as positive when at least two were present. However, reproducibility between operators and centres proved variable.
What did the 2009 IUP consensus establish?
The panel unanimously recommended the Hamburg classification and included stenotic lesions of extracranial venous pathways among congenital truncular venous malformations. This anatomical classification does not demonstrate that CCSVI causes multiple sclerosis or that angioplasty cures it.
What does angioplasty of the jugular and azygos veins involve?
It is an endovascular procedure in which a catheter reaches the vein through peripheral access. After venography, a balloon may be inflated at the narrowed point to widen the lumen. It is invasive and carries risks.
Does CCSVI cause multiple sclerosis?
This has not been demonstrated. Some studies and a meta-analysis found a statistical association, but results were highly heterogeneous. An association does not establish which phenomenon comes first or prove cause and effect.
Does angioplasty cure multiple sclerosis?
No. Controlled studies have not demonstrated an overall clinical benefit sufficient to recommend venoplasty in managing multiple sclerosis. The procedure should not be presented as a cure or replace neurological treatments.
Why did some patients report improvements?
Individual experiences may be authentic, but they cannot independently identify the cause of a change. A fluctuating disease course, concurrent treatments, expectations, rehabilitation, case selection and other factors may contribute. Controlled comparisons and standardised measurements are needed to attribute an effect to the procedure.
What was Dr Ciro Gargano’s experience?
Dr Gargano completed the second-level university Master’s degree in Haemodynamics and Advanced Venous Surgery at the University of Ferrara, passing the final examination on 20 October 2011. This is confirmed by a statement from the Vascular Diseases Centre signed by Professor Paolo Zamboni as Director. He managed a personal series of more than 1,500 procedures on the jugular and azygos veins within a pathway including vascular, neurological and neuropsychological assessment, ultrasound checks and follow-up.
Where can historical testimonials and interviews be found?
Some videos remain available on the historical YouTube channel. Television interviews, articles and documents from the former website are being catalogued and will be republished as a contextualised selection.
Last medical review: August 2026. Informational and historical content; it does not replace a specialist consultation or individual neurological advice.
