How the unique features of the GORE® TIGRIS® vascular stent relate

to optimal clinical outcomes

Maxime Sibé, MDVascular surgeon, Bordeaux, France

Disclosure

Speaker name: Maxime Sibé

I have the following potential conflicts of interest to report:

Consulting

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

I do not have any potential conflict of interest

How the unique features of the GORE® TIGRIS® vascular stent relate to optimal clinical outcomes

• Radial strength M. Sibé

• Accuracy N. Collin

• Flexibility M. Sirvent

• Fracture resistance M. Werner

Men, 67 Y old

Claudicant, smoker, dyslipidemia,

HTA

Walking distance: 100 m

Shortly Calcified lesion popliteal

artery ( stenosis 90%)

previous treatment :PTA + Tigris

stenting

Clopidogrel + Aspirin

PTA

Balloon: 6 / 60

Time of inflation : 3 min

Slowly deflation during 20 sec

Stenting : Tigris 5/ 60

Result after Tigris stenting

M, 59 Y old

HTA, dislipidemia

Coronary disease

Claudicant

Walking distance : 50 m

Thrombosis SFA and popliteal artery

Previous treatment: subintimal recanalisation

PTA/ stenting

Clopidogrel+aspirin

Run off : OK

After PTA

Residual stenosis : hunter calcification

Tigris deployment

Final control

GORE® TIGRIS®

Vascular Stent

BARD® LIFESTENT®

Vascular Stentp-value

Number of Devices (Subjects) 335 (197) 100 (70)

Pre-treatment Lesion Length (mm) 107.6 ± 68.6 117.9 ± 75.4 0.292

Total Stented Length (mm) 129.0 ± 73.3 148.7 ± 75.4 0.057

Number of Stents Implanted to Cover Lesion 196 70 0.033

1 101 (51.5%) 44 (62.9%)

2 55 (28.1%) 22 (31.4%)

3 36 (18.4%) 4 (5.7%)

4+ 4 (2.0%) 0 (0.0%)

Lesion Type 197 70 0.483

Occlusion 83 (42.1%) 26 (37.1%)

Stenosis 114 (57.9%) 44 (62.9%)

Lesion Calcification 189 66 0.442

None/Mild 99 (52.4%) 28 (42.4%)

Moderate/Severe 90 (47.6%) 38 (57.6%)

Tibial Runoff Vessels 187 69 0.156

1 21 (11.2%) 11 (15.9%)

2 106 (56.7%) 30 (43.5%)

3 60 (32.1%) 28 (40.6%)

TIGRIS IDE Study: Lesion Characteristics

GORE® TIGRIS®

Vascular Stent

BARD® LIFESTENT®

Vascular Stentp-value

Number of Devices (Subjects) 335 (197) 100 (70)

Pre-treatment Lesion Length (mm) 107.6 ± 68.6 117.9 ± 75.4 0.292

Total Stented Length (mm) 129.0 ± 73.3 148.7 ± 75.4 0.057

Number of Stents Implanted to Cover Lesion 196 70 0.033

1 101 (51.5%) 44 (62.9%)

2 55 (28.1%) 22 (31.4%)

3 36 (18.4%) 4 (5.7%)

4+ 4 (2.0%) 0 (0.0%)

Lesion Type 197 70 0.483

Occlusion 83 (42.1%) 26 (37.1%)

Stenosis 114 (57.9%) 44 (62.9%)

Lesion Calcification 189 66 0.442

None/Mild 99 (52.4%) 28 (42.4%)

Moderate/Severe 90 (47.6%) 38 (57.6%)

Tibial Runoff Vessels 187 69 0.156

1 21 (11.2%) 11 (15.9%)

2 106 (56.7%) 30 (43.5%)

3 60 (32.1%) 28 (40.6%)

TIGRIS IDE Study: Lesion Characteristics

Radial compression

what we can expect about the new generation of stent in SFA/ popliteal

arteries?

High radial force : calcified lesion requires stents

with a lower rate of long-term fractures

Biomechanical constrains: requiresconformability and flexibility

Is Radial strength still sufficient?

Interwoven nitinol stent showed good results but becareful during the deployment : to avoid elongation / landing zone.

In case of recanalisation in calcified lesions: what wedo?: intraluminal or subintimal procedures?

Preparation of the artery before stenting is a crucial point

Our clinical experience

GORE® TIGRIS® Vascular Stent in superficial femoral and popliteal arteriesMaxime Sibé, MD,a, Adrien Kaladji, MD, PhD,b, Claire Boirat, MD,b, Alain Cardon, MD,b, Xavier Chaufour, MD, PhD,c, Jean-Pierre Bossavy, MD, PhD,c, Bertrand Saint-Lebes, MD,c.

J Vasc Surg. 2017

Single-arm, multicenter cohort study

included 215 patients evaluating 239 lesions

Baseline characteristics

Patient characteristics N=215Mean age (yrs) 74.1 ± 11.7 (range 49 – 102)Men 145 (67.8%)Rutherford

III 114 (48.9%)IV 48 (20.6%)V 67 (28.8%)VI 4 (1.7%)

Lesion characteristics N=239Lesion location

SFA 141 (59%)Popliteal 98 (41%)

Lesion typeStenotic 196 (88.8%) CTO 25 (12.7%)

Lesion length (mm) SFA 82.4 ± 35.0 (range 30 – 200)Popliteal 93.0 ± 55.3 (range 30 – 360)

Outcomes – Patency all lesion

1Y primary patency: 82%

2Y primary patency: 67%

Outcomes – Patency SFA VS Pop

Similar outcomes for SFA and Popliteal lesions supporting the need for conformable stents in this region

12M Primarypatency

18 M Primary patency

24 M Primary patency

SFA 84 - 74%

Popliteal 79% 74% -

Conclusion

• The TIGRIS IDE showed good procedural success when alsotreating moderate and calcified lesions

• Our experience demonstrates a good performance out to 2 years in both the SFA and the popliteal arteries.

• We need comparative studies with longer follow-up to evaluate clinical effectiveness in the future

• Repair SFA and popliteal arteries is an engineering challenge

How the unique features of the GORE® TIGRIS® vascular stent relate

to optimal clinical outcomes

Maxime Sibé, MDVascular surgeon, Bordeaux, France