The Ideal Venous Stent and Early Results from Venous Stent Trials PNEC, Seattle
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1 The Ideal Venous Stent and Early Results from Venous Stent Trials 2017 PNEC, Seattle Bill Marston MD Professor, Div of Vascular Surgery University of N. Carolina
2 DISCLOSURES William Marston, MD Consultant/Advisory Board: Veniti, Cardinal Healthcare, Tactile Medical, Factor Therapeutics, Volcano Inc Stock: Veniti Inc
3 982 iliac lesions treated Characteristics Median age 54 Female:male 2.6:1 CEAP clinical class 2 7% 3 47% 4 24% 5 5% 6 17% J Vasc Surg 2007;46:979
4 Long-term outcomes: Iliac stent patency Median follow-up time 22 months Acute thrombosis 1.5% Iliac vein patency at 72 months 67% primary 89% assisted primary 93% secondary J Vasc Surg 2007;46:979
5 Failure modes of current stents
6 Wallstent: Designed for biliary Inadequate strength at stent ends Migration Imprecise placement leading to need for additional stent or obstruction of contralateral side Fibrous scarring/restenosis Difficulty determining distal end of stent
7 Desirable characteristics for a Flexibility Expansile strength Venous Stent Minimal shortening on deployment for accuracy Resistance to hyperplastic ingrowth Long lengths to reduce need for multiple stents 7
8 Novel venous stents: Design characteristics Veniti stent Nitinol self expanding Closed cell design Increased density No gaps between struts 9F delivery system lengths to 120 mm Diameters 12 to 16 mm 8
9 Radial strength testing Standard bench testing method measures crush resistance of expanded stent in Newtons SS Nit stand Nit Novel 9
10 Current status of venous stent development in US Veniti VICI stent Cook Zilver Venous Both have completed enrollment of venous stenting trials of approx 200 patients each Results expected Q1 2018
11 New Data from Clinical Trials: Leverage to improve QOL and classification systems Volcano Video trial QOL data Veniti stent clinical trial Cook venous clinical trial Does symptom improvement depend on severity of disease?
12 Venous stents in use in Europe Vici venous (Veniti) Zilver venous (Cook) Sinus Venous (Optimed) Bard
13 PTS NIVL Veniti VIRTUS trial Image courtesy of Mr. Stephen Black Objective Safety Assess safety & effectiveness in achieving patency of target venous lesion through 12-M post stent placement 30 days Effectivess Primary 12-M Principle Investigators Study Design Patient Population Pivotol Subjects Core Lab Dr. William Marston Dr. Mahmood Razavi Prospective, multicenter, single arm non-randomized, up to 45 sites worldwide 200 subjects with clinically significant chronic non-malignant obstruction of the iliofemoral venous segment first 30 were feasibility. Two Treatment Groups - 43 NIVL subjects and 127 PTS subjects Venography Syntactx, IVUS St. Lukes, DUS - Vascore Image courtesy of Dr. Mahmood Razavi
14 VIRTUS Study: Feasibility Cohort by DUS (Site Reported & Corelab Analysis) Patency Results of Full Cohort (N=30) Primary Patency Secondary Patency 6 M 96±4% 100% 12 M 90±7% 100% Image courtesy of Dr. Ediberto Soto-Cora
15 VIRTUS Trial Feasibility Cohort Safety Endpoint Primary Safety through 30 Days (n=30) n % Composite Major Adverse Events (MAE) Device or procedure-related death 0 0 Device or procedure-related bleeding 0 0 Device or procedure-related vessel injury 0 0 Device or procedure-related DVT (nontarget vessel segment)* Clinically significant PE 0 0 Embolization of stent 0 0
16 Sinus Venous Stent Designed for implantation in the iliac vein at the iliac confluence High radial force, precise placement Angled leading edge to facilitate treatment of MTS without obstructing contralateral iliac
17 Initial results with Sinus-Venous Stent 75 patients treated 35 non-thrombotic MTS 40 post-thrombotic Implantation success 100% Primary patency 92% at 12 months de Wolfe et al, Eur J Vasc Endovasc Surg 2015;50:518-26
18 Variety of outflow obstruction Type II Type IV Type 1 Type III
19 Further development required Venous confluence device
20 Additional needs for Management of ICVO to move forward Venous stent for inguinal ligament area Device for thrombus > 2-3 weeks old Venous Atherectomy device
21 But there really isn t a large market for these devices
22 C-TRACT Study Effort by group steering ATTRACT trial Randomize patients with severe PTS and ICVO to standard care vs intervention Goal to identify whether venous intervention improves clinically relevant QOL outcomes
23 Questions?
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