1. Medical Director of the Vascular Center
My Choice for the 2 cm Uncomplicated Symptomatic Proximal Popliteal Stenosis
John R. Laird, MD
Professor of Medicine
Medical Director of the Vascular Center
UC Davis Health System

2. John R. Laird Jr. MD
Consulting: Bard Peripheral Vascular, Inc., Boston Scientific Corporation, Medtronic, Inc., Covidien and Abbott Vascular
Grant Support: Atrium Medical Corporation and W. L. Gore and Associates, Inc
Honoraria: Volcano Therapeutics, Inc.
Stocks, Stock Options, other ownership interest: AngioSlide, NextGen Healthcare Information Systems, Inc., BioCardia, Inc., Endoluminal Sciences and Syntervention Reflow Medical
Off-Label: Off-label use of stents

3. Popliteal Artery
Direct extension of SFA as it passes through adductor canal
Located between two heads of gastrocnemius muscle
Anterior to popliteal vein
Genicular and sural branches

4. Popliteal Artery Pathologic Conditions: Atherosclerosis Aneurysm
Trauma
Embolism
Entrapment syndrome
Cystic adventitial disease

5. The Uncomplicated, Symptomatic 2 cm Proximal Popliteal Artery Stenosis
(Rare as Hen’s Teeth)
Post PTA

6. Cystic Adventitial Disease
Figure 14b.
Case History
42 year old male runner
Left lower extremity claudication
Diagnosis?
Treatment?
Figure 14b. A 42-year-old male runner presented with acute claudication of the left lower extremity and was initially thought to have popliteal entrapment. (a, b) Stress (a) and nonstress (b) angiograms depict a similar hourglass-shaped stenosis. (c-e) Sequential axial T2-weighted MR images reveal extensive compression of the popliteal artery by CAD (arrow).
Cystic Adventitial Disease

8. Case History 72 yo male CAD s/p CABG, HTN, Hyperlipidemia
Lifestyle limiting claudication symptoms of right lower extremity
Previous stenting of Left SFA
Non-compressible arteries – ABI’s unreliable
Duplex evidence of significant popliteal stenosis

9. Angiography

11. Treatment Options PTA Cutting/Scoring PTA
Excisional atherectomy (TurboHawk Calcium Cutter)
Orbital/Rotational atherectomy
Stenting

12. Woven Nitinol Design

13. Leipzig Supera Popliteal Registry N = 101

14. Leipzig Supera Popliteal Registry N = 101

15. Post PTA

17. Diffuse Femoropopliteal Disease

18. 5 x 120mm Supera Stents (x2)
Final

19. Popliteal CTO: Interwoven Stents

20. Final Runoff Bent-Knee Angio

21. GORE® TIGRIS Vascular Stent Dual Component Stent Design
Clinically Proven Stent Frame
Nitinol wire
ePTFE Interconnecting Structure
CARMEDA Bioactive Surface

22. TIGRIS: Dual Component Stent Design
Designed to:
Maximize flexibility while minimizing risk of stent fracture
Allow axial compression while resisting stent elongation
Naturally conforms and allows vessel movement 23

23. ETAP Trial
Multicenter, randomized trial of PTA vs. Stenting (LifeStent) for popliteal stenosis
1:1 Randomization
9 Centers in Europe, 246 patients
Primary endpoint: restenosis rate at 24 months
No restriction to lesion length

24. ETAP Trial Technical success 100% in both groups
Stent fracture rate 3.8% at one year
12-Month Primary patency:
LifeStent %
PTA %
12-Month TLR Rate:
LifeStent %
PTA %

25. Case History 72 yo male (retired radiologist)
Previous orbital atherectomy of popliteal artery calcified stenosis (over 2 years ago)
Recurrent left calf claudication
ABI:  0.60
Duplex: Popliteal PSV of 443 cm/sec (PSVR) > 3.5

26. Left Lower Extremity Angio

27. LEVANT 2 Study Procedural Technique
Cross stenosis/occlusion with guidewire and predilate with balloon 1mm < reference vessel diameter
If no flow limiting dissection or residual stenosis > 70%, randomize to DEB vs. POBA
Dilate with DEB matched 1:1 to RVD
Post dilate with standard balloon as necessary to treat recoil/dissection to avoid cross over stenting

30. DEFINITIVE LE Key Eligibility Criteria
Inclusion Criteria
RCC 1-6
≥ 50% stenosis
Lesion Length ≤ 20 cm
Reference Vessel ≥ 1.5 mm and ≤ 7.0 mm
Exclusion Criteria
Severe calcification
In-stent restenosis
Aneurysmal target vessel
SilverHawkTM /TurboHawk™ Peripheral Plaque Excision Systems used in study

31. Study Design and Primary Endpoints
800 patients
47 centers
Claudicants
(RCC 1-3)
598 patients*
Primary patency by Duplex US at 12 mos
CLI
(RCC 4-6)
201 patients
Freedom from major unplanned amputation at 12 mos
*1 censored due to informed consent violation

32. Baseline Demographics
Claudication (RCC 1-3)
(n=598)
CLI
(RCC 4-6)
(n=201)
All Subjects (RCC 1-6)
(n=799)
Age (yrs)* 69 72 70
Female
44%
50%
45%
History and Risk Factors
Angina
23%
18%
22%
Diabetes*
47%
69%
52%
Hypertension
92%
Hyperlipidemia*
86%
76%
84%
Renal Insufficiency*
17%
Current/Previous Smoker*
54%
36%
49%
* p<0.05, claudicant vs. CLI

33. Baseline Lesion Characteristics Core Lab Reported
Claudication (RCC 1-3)
CLI
(RCC 4-6)
All Subjects (RCC 1-6)
Number of Patients
598
201
799
Number of Lesions
743
279
1022
Mean Length (cm)
7.5
7.2
7.4
Baseline Stenosis (%) 73 76 74
Occlusions (%) 17 30 21
Anatomic location based on proximal edge of lesion treatment, % (n)
SFA
72% (536)
48% (135)
66% (671)
Popliteal
15% (114)
17% (48)
16% (162)
Infrapopliteal
13% (93)
34% (96)
18% (189)

34. Peri-procedural Outcomes
Claudication (RCC 1-3)
CLI
(RCC 4-6)
All Subjects (RCC 1-6)
Device Success (≤30% stenosis after directional atherectomy)
Investigator-Reported
87%
Core Lab
76%
72%
75%
Procedure Success (≤30% stenosis at end of procedure)
99%
98%
91%
83%
89%
Therapy
Pre-Directional Atherectomy PTA 9%
Post-Directional Atherectomy PTA (no stent)
33%
Mean pressure
6.6 atm
Bail-Out Stent 3%

35. Stent-like Primary Patency Claudicant Cohort
743
Lesions
7.5 cm
Mean lesion length
72.7%
Mean baseline stenosis
PSVR ≤ 3.5
82%
PSVR ≤ 2.4
78%
36 |

36. Making Sense of it All
For the uncomplicated 2 cm proximal popliteal stenosis – POBA is probably adequate
Non-stent options reasonable – DCB, atherectomy
Favorable early experience with newer, flexible nitinol stents (Supera stent for calcified/complicated lesions)