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Patency rates and clinical results of a dedicated closed-cell design stent for thetreatment of iliac vein lesion
Michael K. W. Lichtenberg MD, FESCVascular Centre Arnsberg / German Venous Centre Arnsberg
Conflict of Interest - Disclosure
Within the past 12 months, I or my spouse/partner have had a financial
interest/arrangement or affiliation with the organization(s) listed below.
Affiliation/Financial Relationship Company
1. Honoraria for lectures: CR Bard, Veniti, AB Medica, Volcano, Optimed
GmbH, Straub Medical, Terumo, Biotronik, Veryan
2. Honoraria for advisory board activities: Veniti, Optimed GmbH, Straub
Medical, Biotronik, Veryan, Boston Scientific
3. Participation in clinical trials: Biotronik, CR Bard, Veryan, Straub Medical,
Veniti, TVA Medical, Boston Scientific, LimFlow
4. Research funding: Biotronik, Boston Scientific, Veryan, Veniti, AB Medica
• Self-expandable
• Crush resistant across length of stent
• Sufficient chronic outward force
• Sufficient wall coverage
• Flexibility sufficient to resist kink at physiological angles
• Durability allowing repeated shortening, twisting, and bending at the groin
• Minimal foreshortening on deployment and balloon dilation
• Predictable, consistent deployment
Desired Venous Stent Attributes
Goal… Ideal BALANCE strength, flexibility, and lumen quality.
C6, 58 year female with chronic outflow obstruction
2 Sinus XL Stent (22 x 80 mm)4 x Veniti Vici Stent (16 x 120 mm + 14 x 60 mm)
Closed Cell Open Cell
Design Attributes • All struts interconnected • Not all struts interconnected
Performance
Crush Resistance ++ +Flexibility + ++Coverage ++ +
Performance Characteristics
Radial Resistive Force
• Ability to withstand uniform CIRCUMFERENTIAL load
• Not closely representative of diseased veins.
Stent Strength Attributes
Crush Resistance
• Ability to withstand non-uniform FOCAL load.
• More closely represents condition of diseased veins.
FOCAL LOAD CIRCUMFERENTIAL LOAD
VICI Lumen QualityUniform Strength and Coverage
Gap
Gap No Gap
24 Struts12 Struts8 Struts4 Struts
Closed-cellOpen-cellOpen-cell
Str
en
gth
Co
ve
rag
e
VICI STENT
VIRTUS Feasibility Trial Design
ObjectiveAssess safety & effectiveness in achieving patency of target venous lesion through 12-M post stent placement
Safety MAEs @ 30 days
Effectiveness Primary Patency @ 12-M
PrincipalInvestigators
Dr. William Marston Dr. Mahmood Razavi
Study DesignProspective, multicenter, single arm non-randomized, up to 45 sites worldwide
PatientPopulation
200 subjects with clinically significant chronic non-malignant obstruction of the iliofemoral venous segment – first 30 were feasibility.
Etiologies: Post Thrombotic (75%); Non Thrombotic (25%)
Core Labs
Venography: SyntactxIVUS: St. LukesDUS: VasCore/MGHX-Ray: Syntactx
Non-thrombotic
Post-thrombotic
Image Courtesy of Mr. Stephen Black
Image Courtesy of Mr. Mahmood Razavi
Demographics & Medical HistoryFemale 24 (80%) Male 6 (20%)
Age 44.4 ±14.1 years
CEAP* Baseline
0 3% (pain by VCSS Score of ≥2)
1 0%
2 0%
3 47%
4 40%
5 7%
6 3%
Etiology
PTS 63%
NIVL 37%
Target Lesion Location
Lesion1 Location
Patients N = 30
Left N = 25 (83%)
Right N = 5(17%)
CIV lesions 26/30 (87%)
EIV lesions 18/30 (60%)
CIV & EIV lesions 15/30 (50%)
Lesions that extended into CFV2 9/30 (30%)
Average Target Lesion Length
11.9 ±6.7 cm
1. Some patients have more than 1 lesion or lesion extends in multiple vein segments2. No lesions were isolated to the CFV alone
Patency by Duplex Ultrasound(Corelab Analysis)
Courtesy of Dr. Ediberto Soto-Cora
Patency Results of Feasibility Cohort (N=30)
Primary Patency1 Secondary Patency
1- M 93% 100%
6 – M 90% 100%
12 – M 93% 97%
Patency Results at 12-Months (Site Reported)
Primary Patency1
Secondary Patency
Full Cohort (N=30)87%
(26/30)97%
(29/30)
Etiology
NIVL 37% 100% (11/11) 100% (11/11)
PTS 63% 79% (15/19) 95% (18/19)
All patients enrolled in the study will be followed until study completion
Patency by Lesion Etiology(Site Reported)
Courtesy by Dr Michael Sadek
Safety Endpoint Results
Primary Safety Endpoint through 30 Days (n=30)
n %
Composite Major Adverse Events (MAE) 0 0
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 (non-target vessel segment)*
0 0
Clinically significant PE 0 0
Embolization of stent 0 0
No MAEs @ 30 days
VCSS Pain Scale
45% had “substantial symptomatic improvement” (VCSS ≥2 ) @12-M
CIVIQ-20
Arnsberg Venous RegistryVENITI VICI VENOUS STENT® System
ObjectiveAssess safety & effectiveness in achieving patency of target venous lesion through 36 months post stent placement (VENITI VICI Stent)
Effectiveness Primary Patency @ 12-M
Principle Investigators Dr. Michael Lichtenberg Dr. Rick de Graaf
Study DesignOngoing prospective, single arm, single center non-randomized registry FU 1 (4 weeks), FU 2 (6 months), FU 3 (12 months), FU 4 (24 months), FU 5 (36 months)
Patient PopulationSubjects with clinically significant chronic non-malignant obstruction of the iliofemoralvenous segment
Demographics N=90
Age in years(mean ± SD [range]) 57.4 ± 16.4 [19-84]
GenderMaleFemale
47.8% (N=43)52.2% (N=47)
EthnicityCaucasian 100% (N=90)
Medical history N=90
Coagulation disorder 4.4% (N=4)
Pulmonary embolism 24.4% (N=22)
Deep vein thrombosis 47.8% (N=43)
History of cancer 14.4% (N=13)
Lesion analysis N=90
Sides treatedBothLeftRight
7.8% (N=7)74.4% (N=67)17.8% (N=16)
Lesion location(s)
Left:Common iliac veinExternal iliac veinCommon femoral veinCommon iliac vein, external iliac veinCommon iliac vein, external iliac vein, common femoral veinExternal iliac vein, common femoral vein
Right:Common femoral veinCommon iliac veinExternal iliac veinCommon iliac vein, external iliac veinCommon iliac vein, external iliac vein, common femoral veinExternal iliac vein, common femoral vein
Both:External iliac (R), common iliac (L) veinExternal iliac (R), common iliac (L), external iliac (L) veinCommon iliac (R+L), external iliac (L) veinCommon iliac (R+L), external iliac (R+L), common femoral (L) veinCommon iliac (R+L), external iliac (R+L), common femoral (R+L) vein
37.8% (N=34)4.4% (N=4)2.2% (N=2)17.8% (N=16)8.9% (N=8)3.3% (N=3)
2.2% (N=2)3.3% (N=3)6.7% (N=6)1.1% (N=1)1.1% (N=1)3.3% (N=3)
1.1% (N=1)2.2% (N=2)2.2% (N=2)1.1% (N=1)1.1% (N=1)
64 / 90 (71%) patients: Postthrombotic
26 / 90 (29%) patients: NIVL
Effectiveness analysis
0
10
20
30
40
50
60
70
80
90
100
FU 4 w FU 6 mo FU 12 mo
% Patentcy analysis
NIVL PTS
N=50N=82 N=21
100 % 100 % 100 %
97% 90 %87 %
0
2
4
6
8
10
12
14
Baseline FU1 FU2 FU3
Mean VCSS score (±SD)
N=90 N=82 N=50 N=21
9.2
5.34.9
4.3
Claudication, Pain, Swelling,
Ulceration improvemnt
0
0.5
1
1.5
2
2.5
3
3.5
4
4.5
5
Baseline FU1 FU2 FU3
Mean CEAP score (±SD)
N=90 N=82 N=50 N=21
3.6
2.6 2.7
2.4
Conclusions
• Initial 6 and 12-Month efficacy data in the VIRTUS Trial and
Arnsberg Registry are better than reported data:NIVL PTS
Primary patency: 100% 87%Secondary Patency: 100% 97%
• Safety data is positive
• Patients feel substantially better
85% of population showed symptomatic improvement after venous stenting (VCSS ≥2) at 12-Months
45% had “substantial symptomatic improvement” (VCSS ≥2 ) at 12-M
• Venous anatomy and disease require dedicated venous stents
24
Patency rates and clinical results of a dedicated closed-cell design stent for thetreatment of iliac vein lesion
Michael K. W. Lichtenberg MD, FESCVascular Centre Arnsberg / German Venous Centre Arnsberg