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VeClose Study Overview Randomized U.S. Multicenter Trial
VeClose Study Overview Randomized U.S. Multicenter Trial
2017ablationadverseassessmentscentersCharing CrossclosurecomparingendovenousMedtronicnoindexpatencypatientsradiofrequencyrandomizedResearchtrialVeCloseveinVenaSealvenous
Baseline Characteristics and Pain Scales of VenaSeal and RFA
Baseline Characteristics and Pain Scales of VenaSeal and RFA
2017chapterCharing Crossdifferencesfull videoMedtronicnoindexpainpatientsradiofrequencyrandomisedResearchscoresVeCloseVenaSeal
NASAIDs Narcotic Use and Ecchymosis Assessed at Day 3 - VeClose Primary Endpoint
NASAIDs Narcotic Use and Ecchymosis Assessed at Day 3 - VeClose Primary Endpoint
2017Charing CrossMedtronicnarcoticnarcoticsnoindexocclusionpercentradiofrequencyResearchstatisticallyVeCloseVenaSeal
VCSS AVVQ and EQ5D Improvement Maintained and Equal Over 3 Years - Adverse Events Reported
VCSS AVVQ and EQ5D Improvement Maintained and Equal Over 3 Years - Adverse Events Reported
2017adverseCharing CrossdistaleventsMedtronicnoindexpatientrefluxResearchseveritythrombosisVeCloseveinVenaSealvenous
Summary of VeClose Trial After 3 Years
Summary of VeClose Trial After 3 Years
2017Charing CrosseventsMedtronicnoindexradiofrequencyrandomizedResearchsummarytrialVeCloseVenaSeal
Transcript

Okay, well, we'll move over the next session and, I'd like to introduce ...gibson ...the podium to speak about endovenous adhesive vs radiofrequency patients...three years which is a long term results of a veclose study of ...thank you so, I'm going to present today for the first-time in europe the thirty six ...results from the veclose trial these were first presented a few days ago in miami. And, these are my disclosures.

Sorry. So, the veclose trial was a randomized controlled trial comparing the venaseal... akerley closure system to radiofrequency ablation for treatment of incompetent great And, this was a us multi-center trial that was randomized and the primary end point was to show noninferiority

at three months in terms of anatomical closure rates comparing venaseal ...radiofrequency search hundred-forty to patients enrolled and the follow-up visits shown here twenty those patients were role in patients to familiarize the sites with the new technique and two hundred-twenty to ...randomized so our primary end point was complete closure of the target vein at three months and complete closure was defined as a vein showing no

discrete areas of patency that were exceeding five centimeters either by flow or by compression secondary end points included pain during the procedure and bruising at day three. Additional assessments included venous clinical severity scores and quality of life measures using the aberdeen varicose vein questionnaire and...generic ...five de we also compared adverse events are related to the

target means and looking at adverse very rate of disease-specific invents these were the participating centers in the united states. And, again, our study ...so two hundred forty two patients were treated to hundred-twenty to were randomized ...and eight in the venaseal group and a...and fourteen in the radiofrequency group there were pre-operative evaluations baseline assessments and follow-up as shown.

So, baseline characteristics were similar between the two groups of note the gs ...on average was a fairly small around six and dc assess and quality of life scores between the two groups were equivalent. So, the amount of sano akerley delivered on average to ...gs v was about one-point-two cc's. One thing that we noted...although there were numeric differences there were no statistical

differences in pain between the two procedures however this was on a scale of zero to ten and even in the radiofrequency group with tumescence these pain skills in both groups of patients were fairly low and my opinion is the reason for that is that when you ask patients to participate in a randomised trial in which they can I have no sedation and they volunteer to have their treatment pick for them you don't pick patients with low pain tolerance so that's why I think are pain scores in both groups.

in terms of n said and narcotic use there was no difference between the two groups in the first twenty four hours only one patient required narcotics and that was in the one of the radiofrequency patients. We did find that there was significantly less bruising in the venaseal group compared to the radiofrequency group at day three. The primary end point three months was equivalent between the two groups complete occlusion was ninety nine percent in the venaseal group and...five-point-four percent and

...and this data's been previously presented. This is the new data so, at thirty six months the closure rate for venaseal is ninety-four point ninety four ninety four point four percent and rsa group ninety ...percent and this is statistically significant highly statistically significant for noninferiority of venaseal at three years.

So, patients don't come to us complaining of reflux of saying that's why they're there nor do they come back and say they're happy because they're veins closed they care about venous clinical severity what the severity their symptoms and their quality of life so I think these next slides are really important so we see that in both groups out to three years improvements in vc ss score are maintained and...between each other. And, we see this also with the aberdeen varicose vein questionnaire that

they are the same between the two groups and still sustained at three years. then finally the eq five d again no difference between the two groups at three years. Adverse events between...two years in three years are shown here...were ...adverse events both of them in the venaseal group one patient had a late onset of phlebitis in her distal gs v just above the and, the second patient heady scar that the

investigator thought was more prominent than it should be at the access site there were no reports of deep vein thrombosis in this cohort no allergic revenge of events and no in an anticipated adverse events so the largest number of adverse events occurred in the first thirty days and were mild and self-limited.

So, in summary for through at three years veclose trial showed that venaseal has a non-inferior closure rate compared to radiofrequency of ninety four

point four percent we had statistically significant improvements in baseline from dc...aberdeen varicose vein questionnaire...five de at three years these improvement seem to be maintained with no difference between the two patient groups there are no reported dts or allergic reactions or other serious adverse events through thirty six months early events were mild and self-limiting and we had few delayed events so in

summary the veclose randomized clinical trial shows that there is the venaseal safe and reliable as a nonthermal nontumescent treatment option out to thirty six. Nothing.

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