FDA Clinical trial on CCSVI for MS
 

Here it is! What we have been waiting for. It is not yet recruiting but at least clinical trials will be starting.

http://clinicaltrials.gov/ct2/show/N...m=ccsvi&rank=1

Study To Evaluate Treating Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis Patients

This study is not yet open for participant recruitment. Verified by The Vascular Group, PLLC, March 2010 First Received: March 17, 2010 No Changes Posted


Estimated Enrollment: 500
Study Start Date: April 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:

Procedure: Angioplasty To identify the presence of CCSVI, all patients will undergo a clinical evaluation by a neurologist, a duplex ultrasound of central extracranial venous system, an MRV, and a venogram.

The decision to enroll patient in percutaneous angioplasty for CCSVI will be made at the time of venogram, in select patients that have greater than or equal to 50 percent stenosis of the extracranial central veins including the internal jugular veins and the azygos vein.

Extracranial venous ultrasound will be performed at 3, 6, 12, 18, and 24 months following the procedure or if clinical symptoms recur. MRV and venograms will be performed at 12months and 24 months or if clinical symptoms recur.

See link to FDA for more..

This is wonderful! Hopefully the brave souls that volunteer for the trial will do well and have no negative effects from the procedure.

gmi

The should have a bunch of recruits for this, I hope. It could be a danger, though, if they are going to use stents.:eek:

Thanks, Lady.:hug:

I'll do it in heartbeat if they'll have me. I'm not so brave, I'm kind of desperate!




Sal, I'd rather die trying than just do nothing but guarantee that I'll stay on this miserable course. Not kidding.

I applied quite a long time ago. :rolleyes: but I doubt I will hear anything.

I will let you know. :grouphug:

My age may be against me, not the MS. I think they are looking for a younger group. They don't mention age, so we'll see. :) They only need 500 people. :cool:

The waiting list for the Buffalo study was up to 12 thousand, just for testing. This is the whole thing. Testing and procedure. I don't believe stents are involved, just balloon dilation, if needed, they didn't say.

Well said and you know we understand. :hug: