POČINJE NOVA STUDIJA O CCSVI U SAD-u

KLINIČKA STUDIJA O CCSVI

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Utility of Chronic Cerebrospinal Venous Insufficiency Percutaneous Angioplasty for Multiple Sclerosis: The Albany Vascular Group Study
Primary Outcome Measures:
•Incidence of major adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
The evaluation of safety will be defined as the incidence of major adverse events at 30 days following the index procedure. The evaluation of feasibility and efficacy will be determined by those patients that do not have more than 50 percent restenosis within the 30 day time frame.


•Neurological assessment of MS [ Time Frame: 1 year ] [ Designated as safety issue: No ]
An independant neurologist will assess the number of MS attacks that have occurred during one year follow up period.

•MRI/MRA evaluation of MS lesions [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Evaluation of imaging to reveal local iron content, change in MS lesions and oxygen saturation changes using conventional MRA/MRI methods by an independant radiologist.
Secondary Outcome Measures:


•Mortality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
All cause mortality will be evaluated through one year.


•Major adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Incidence of all major adverse events will be collected for one year.


•Identification of central venous stenosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Evaluation of the correlation between MRV, Duplex Ultrasound and Venogram in identifying central venous stenosis.

Estimated Enrollment: 600
Study Start Date: August 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

Arms
Venoplasty (treatment): Active Comparator

Patients will be randomized to treatment or non-treatment arm with a 2:1 ratio. Patients who meet the inclusion/exclusion criteria and who are randomized to the treatment arm of the study will receive venoplasty at the time of the diagnostic venogram.

Procedure: Venoplasty
Venous access is obtained from the groin through the femoral vein. The catheter will be advanced into the veins in the neck and chest. Angiographic images will be taken of the extracranial venous system as well as the azygous vein. These images will be used to confirm CCSVI. Venoplasty is performed by inserting an additional catheter with a balloon at the tip. The balloon will be inflated to open the vessel. Once dilation of the vessel is confirmed, the venous sheath will be removed and manual compression applied to the groin access.


Assigned Interventions
Sham procedure (non-treatment): Sham Comparator
Patients will be randomized to treatment or non-treatment with a 2:1 ratio. Patients who meet the inclusion/exclusion criteria and who are randomized to the non-treatment arm of the study will receive the diagnostic venogram only.

Procedure: Sham procedure (non-treatment)
Venous access is obtained from the groin through the femoral vein. The catheter will be advanced into the veins in the neck and chest. Angiographic images will be taken of the extracranial venous system as well as the azygous vein. These images will be used to confirm CCSVI. Since the patient has been randomized to the non-treatment arm of the trial, the procedure will end without venoplasty. After completion of the diagnostic venogram, the venous sheath will be removed and manual compression applied to the groin access.


Eligibility
Ages Eligible for Study: 18 Years to 55 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:

•Must be 18 years old or greater and less than or equal to 55 years of age
•Score of 0 to 7 on the EDSS scale
•Diagnosis of relapsing remitting or secondary progressive Multiple Sclerosis by a neurologist and confirmed by one of the independent study neurologists
•Presence of greater than or equal to 50 percent stenosis of the extracranial veins as determined by venogram
•Informed consent signed by patient

Exclusion Criteria:
•Patient is unwilling to comply with the follow up
•Patient is pregnant
•Diagnosis of primary progressive MS by a certified neurologist confirmed by one of the study neurologists
•Presence of less than 50 percent stenosis of the extracranial veins as determined by venogram
•Presence of other medical illnesses or a psychiatric condition that in the opinion of the investigator may cause the subject to be non-compliant with the protocol requirements
•Life expectancy is less than one year
•Lack of mental capacity to consent
•Creatinine level of greater than 2.5 or is dialysis dependant
•Enrollment in another clinical study

Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089686


Contacts
Contact: Megan Wilcox, LPN 518-218-7909 wilcoxm@albanyvascular.com


Locations
United States, New York
The Vascular Group, PLLC, The Vascular Health Pavillion Recruiting
Albany, New York, United States, 12205
Contact: Megan Wilcox, LPN 518-218-7909 wilcoxm@albanyvascular.com

Principal Investigator: Manish Mehta, MD, MPH