UBC Canada CCSVI clinical trial results coming March 8th

A forum to discuss Chronic Cerebrospinal Venous Insufficiency and its relationship to Multiple Sclerosis.

UBC Canada CCSVI clinical trial results coming March 8th

Postby Cece » Tue Feb 28, 2017 12:15 pm

https://www.facebook.com/CanadianNeurov ... NE&fref=nf
UBC CCSVI clinical trial results to be presented Wednesday, March 8, 2017 at SIR meeting in Washington DC:
A Multicenter Prospective Randomized Blinded Sham Controlled Trial Of Jugular Venoplasty In Multiple Sclerosis: Week 48 Result

Wed, 3/8/2017: 10:35 - 10:43 AM
Marriott Marquis Washington DC

Authors:
L Machan1, A Traboulsee2, D Klass2, B Hardy3
Institutions:
1University of British Columbia Hospital, 2University of British Columbia
3University of Manitoba,

Purpose:
To compare the clinical efficacy of balloon versus sham venoplasty of jugular and azygos vein stenoses in patients with multiple sclerosis 48 weeks post procedure.

Materials:
MS patients, including relapsing and progressive, from 4 academic MS clinics, recruited after clinical and ultrasound screening were blinded by deep conscious sedation. If catheter venography confirmed jugular or azygos vein stenosis they were prospectively randomized 1:1 intra-procedure by sealed envelope to receive balloon or sham venoplasty of all stenoses. Patient questionnaires were given at baseline, 24 hours and 12 weeks, physical exam at the baseline and at weeks 12, 24, 36, and 48, and MR at baseline and weeks 24 and 48. Patients, clinical neurologists, research staff and radiologists reporting MRIs were all blinded. Safety outcomes including serious adverse events, venous thrombosis, and restenosis were monitored by an independent data safety monitoring board, and clinical trial monitors provided trial oversight. Patients initially randomized to venoplasty received a sham procedure 1 year later, and vice versa. Extensive efforts were made so the patient experience was the same for both procedures.

Results:
274 patients were screened and 104 randomized. All patients were followed up to 48 weeks. Outcomes included patient reported quality of life, fatigue scales, EDSS, protocol defined relapses, and new MRI disease activity (gadolinium enhancing T1 and/or new T2 lesions). Database lock to week 48 was completed December 23rd, 2016. Statistical analysis is underway.

Conclusions:
This will be the first presentation of a randomized, double blind clinical trial of jugular and azygos venoplasty in MS, including patient reported, clinical, and MRI outcomes. The presentation will include all data from the first 48 weeks in all patients after their first procedure only, comparing sham to venoplasty.

Frankly this is terrifying. My fears are greater than my hopes. I want them to have done the procedure expertly and captured accurate data and the data to be supportive.
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Re: UBC Canada CCSVI clinical trial results coming March 8th

Postby lorimayb » Tue Mar 07, 2017 4:47 pm

Doesn't appear to include blood flow measurements...http://ccsviinms.blogspot.ca/2017/03/ub ... trial.html
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Re: UBC Canada CCSVI clinical trial results coming March 8th

Postby 10yearsandstillkicken » Wed Mar 08, 2017 8:51 am

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Re: UBC Canada CCSVI clinical trial results coming March 8th

Postby Cece » Wed Mar 08, 2017 9:16 am

Thanks for linking it, 10yearsandstillkicken. Frustrating results. We'll need to see the full study and methodology and then figure out where the researchers should go from there, assuming there are still researchers interested. The need may be to separate the two definitively so that MS and CCSVI can be researched as separate disease/syndromes. When they say they ballooned the area of narrowing, I would want to know if that was typically at the area of the valves, because if they were ballooning elsewhere in the jugulars such as at the skull base where many people have a narrowing, then that would make the results less convincing. And yes did the area of narrowing stay open seems to be unanswered. Ugh though! Not the results we would've hoped for. Back when the study started, it wasn't the study we were hoping for either.

Slideshow here:
http://www.ctvnews.ca/health/study-find ... -1.3315927

We are seeing that the procedure is very safe. The sham group had more adverse events than the venoplasty group. And there were no thromboses.
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