1. Con: The Answer is You Don’t Know
Iliac and Femoral Stent Trials are a Waste of Time and Taxpayer Money
Con: The Answer is You Don’t Know
David H. Deaton, MD
Chief, Endovascular Surgery
Georgetown University Hospital

2. David H. Deaton, MD DISCLOSURES Consulting Fees Honoraria
Aptus Endosystems, Inc., ROX Medical
Honoraria
m2s, Inc.
Grants/Contracted Research
Boston Scientific Corporation, Terumo Medical Corporation
I intend to reference unlabeled/ unapproved uses of drugs or devices in my presentation.
I intend to reference the published data from FDA sanctioned trials of devices that have not been approved yet. I will describe these devices and how they are physically different from current devices.

3. Pre Test Are bile ducts different than blood vessels?
A) no, they’re both tubes
B) no, they both accept a guidewire and a balloon
C) no, they both carry liquids
D) A,B, and C are correct
E) Yes

4. They’re all the same: Boats

5. Are different vascular beds really all that different?
YES
Carotid – high flow, focal disease, sensitive end organ
Iliac – Intracavitary, often calcified, short
Femoral – Extracavitary, enveloped by muscle / fascia, long
Tibial – Extracavitary, small vessels, diffuse disease

6. Do we need to test devices in different environments?
Journal of Vascular Surgery, Volume 48, Issue 2, Pages , August 2008

7. The SFA Environment
See p.7
90° flexion
0° flexion

8. The SFA Environment
See p.7

9. Can small changes make big differences in outcome? YOU BETCHA!
The deHavilland Comet 1
WindowShape

10. Stent Patterns SENTINOL ABSOLUTE PRO ABSOLUTE XCEED LIFESTENT
FLEXSTAR XL
PROTEGE
EVERFLEX
E·LUMINEXX
SMART
CONTROL

11. Clinical Rates of Stent Fracture in the SFA
Duda SH, et al. Circ. 2002; 106: Schillinger M, et al. New Engl. J. Med. 2006; 354: Schlager O, et al. J. Endovasc. Ther. 2005; 12: Krankenberg H, et al. Circ. 2007; 116: Katzen BT. Transcatheter Cardiovascular Therapeutics, Washington, Scheinert D. Leipzig Interventional Course, Leipzig, Ferreira M, et al. Eur. J. Vasc. Endovasc. Surg. 2007; 34: Schroë H, et al. CIRSE, 2006; Duda S. Leipzig Interventional Course. Leipzig, Germany, 2009.

12. S.M.A.R.T. Stent Fracture in SIROCCO
Lansky AJ. Angiographic analysis of strut fractures in the SIROCCO trial and relationship to adverse clinical events. Transcatheter Cardiovascular Therapeutics, Washington, D.C., 2004.

13. Instent Restenosis

14. Modern Stent Manufacturing
The Devil is in the details…..
Modern Stent Manufacturing
Raw Tubing
Laser Cut Stent
Descaled Stent
Finished Stent
START
Laser Cutting
Descaling
Electropolishing

15. Caveats
Trials for indication should be limited to applications that are clinically and physiologically different
Trials should be limited to applications that are likely to see significant clinical usage

16. Considerations Clinical need Do trials inhibit clinical practice…
Unmet clinical need, or….
Yet another stent without demonstrated additional benefit
Do trials inhibit clinical practice…
No, but unregulated use with bad long-term outcomes will threaten all endovascular
Who’s being regulated ?
Industry not Physicians

17. despair.com

18. Thank you