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)

Cell Architecture

• All Internal inflection points are connected by bridging elements.

• Regular peak-to-peak connections.

• Uniform surface, regardless of the degree of bending.

• Generally less flexible than a open-cell design.

Closed-cell stents have an intrinsically greater potential to scaffold

and support thrombogenic material away from the blood flow.

Open-cellClosed-cellBasic design concept.

Cell shape and

bridging element

designs varies among

stent manufacturers.

VICI VENOUS STENT® DESIGN

Self-expanding nitinol- 12, 14, and 16mm diameter

- 60, 90, and 120mm length.

Closed-cell Geometry

Designed for

Strength High crush resistance

Flexibility Multi-directional

Uniform shape (end-to-end)

Lumen quality

Coverage No gaps, closed-cell

Deployment Predictable placement Closed-Cell

Alternating Curved Bridges

Flexibility

Sinusoidal rings

24 Struts per ring

Strength

Closed Cell Open Cell

Design Attributes • All struts interconnected • Not all struts interconnected

Performance

Crush Resistance ++ +Flexibility + ++Coverage ++ +

Performance Characteristics

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

Improvement in % Lesion Stenosis

% Lesion StenosisPre Procedure by Venogram (Site

Reported)

% Lesion StenosisPost Procedure by

Venogram (Site Reported)

Full Cohort N=30 85.2±17.2 1.8±3.8

Gender

Female 80% 88.4±15 1.5±3.6

Male 20% 73.2±19.4 2.8±4.5

Etiology

PTS 63% 89.3±16.3 2.1±4.2

NIVL 37% 77.5±16.1 1.4±3.1

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%

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

Patient Outcomes in the VIRTUS Trial

Using QOL and Patient Outcome Data to Evaluate How Patients Feel

Three different scales were used in VIRTUS to evaluate QOL VCSS

VAS

CIVIQ-20

VCSS Pain Scale

45% had “substantial symptomatic improvement” (VCSS ≥2 ) @12-M

VAS Scale

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 improvement

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

27

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