1. Intraluminal Coronary Reentry results of the US IDE Trial for the Bridgepoint Medical Crossboss and Stingray Systems
Craig A. Thompson, M.D., MMSc.
Director, Invasive Cardiology and Vascular Medicine
Yale University School of Medicine/Yale New Haven Hospital
Executive Director, Yale-University College London Cardiovascular Device Development Program
Consultant (Hon) Heart Hospital, London and London Chest Hospital

2. Craig A. Thompson, MD Consulting Fees Abbott Vascular Bridgepoint
Terumo
Volcano
I intend to reference off label or unapproved uses of drugs or devices in my presentation.
I intend to discuss DES, guidewires, PTCA balloons/catheters in CTO

3. FAST-CTOs Overview
FAST-CTOs: Facilitated Antegrade Steering Technique in Chronic Total Occlusions
Objective: demonstrate safety and effectiveness of BridgePoint Medical CTO System compared to historical controls
BridgePoint Medical CTO System
CrossBoss CTO Catheter
Stingray CTO Re-Entry System
Stingray CTO Orienting Balloon Catheter
Stingray CTO Re-Entry Guidewire

4. The CrossBoss™ CTO Catheter
CrossBoss is designed to quickly and safely deliver a guidewire via true lumen or subintimal pathways
Multi-wire coiled shaft
Tracks via FAST Spin Technique
Highly torqueable coiled-wire shaft
FAST Spin reduces push required to cross CTO
Atraumatic distal tip advanced across a CTO ahead of the guidewire
OTW 0.014” guidewire compatible

5. The Stingray™ CTO Re-Entry System
Stingray System (catheter and guidewire) is designed to accurately target and re-enter the true lumen from a subintimal position
Unique self-orienting balloon has a flat shape for true lumen targeting
180° opposed and offset exit ports for selective guidewire re-entry
Re-entry probe at Stingray Guidewire tip

6. Crossing and Reentry LAD CTO

7. FAST-CTOs Personnel/Committees
National Principal Investigator
Patrick Whitlow
Steering Committee
William Lombardi
Craig Thompson
Michael Wyman
Data and Safety Monitoring Committee
David Cox (chair)
Joseph Babb
Franz Reisdorf
Jeng Mah

8. FAST-CTOs Study Design
149 Patients, 20 Centers
Multicenter, non-randomized, IDE study
Historically-controlled
Control literature consisted of similarly designed CTO device trials with similar technical success and safety measures

9. FAST-CTOs Endpoints Primary Effectiveness Endpoint
Technical Success: BridgePoint device facilitation of guidewire placement in true lumen distal to CTO
Historical control rate: 59%
Min rate required for successful trial: 61% (α=0.05, β=0.20)
Primary Safety Endpoint
30-day MACE (major adverse cardiac events)
Death, STEMI, NSTEMI (CK>2x ULN +CK-MB), & TLR
3 serial post-procedure blood draws for NSTEMI determination
All events adjudicated by Data and Safety Monitoring Committee
Historical control rate: 6.9%
Max rate allowed for successful trial: 8.5% (α=0.05, β=0.20)
Secondary Endpoints
Procedure time and fluoroscopy time
Historical controls: 146 min and 53 min respectively

10. Major Inclusion/Exclusion Criteria
CTO ≥90 days old refractory to wire crossing:
Previous failed crossing attempt
Attempt to cross with wires in min fluoro time
Subintimal guidewire during attempt to cross
Satisfactory distal vessel visualization:
Distal vessel ≥1.5mm diameter
≥10mm proximal to major distal bifurcation
Angina/ischemia caused by CTO vessel
SVG or in-stent CTOs excluded
Aorto-ostial proximal cap (ostial bifurcation origins considered) excluded
Note: no exclusion for CTO length

11. FAST-CTOs Enrollment by Site
Site Name PI
# Pts
Minneapolis Heart Institute/Abbott Northwestern
Nick Burke 20
North Cascade Cardiology/St. Joseph Hospital
Bill Lombardi 19
Torrance Memorial Medical Center
Mike Wyman 15
Columbia University Medical Center
Stone/Moses
Dallas VA Medical Center
Manos Brilakis 14
Yale-New Haven Hospital
Craig Thompson 13
St. Luke’s Medical Center
Rich Heuser 11
Mayo Clinic/St. Mary’s Hospital
Chet Rihal 10
Stanford University Hospital
Alan Yeung 7
University of California at Davis Medical Center
Reggie Low 6
Cleveland Clinic
Pat Whitlow 4
Prairie Cardiovascular Consultants
Tony DeMartini
Dartmouth-Hitchcock Medical Center
John Jayne 3
Mid-America Heart Institute/St. Luke’s Hospital
Aaron Grantham 2
Scripps Green Hospital
Dave Kandzari
Intermountain Medical Center
Jim Revenaugh
TOTAL
147

12. FAST-CTOs Patient Demographics
Measure
Overall
(n=147)
Mean Age
63 ± 9
% Male
86%
Diabetes (type I or II)
33%
Angina Pectoris
Prior CABG
22%

13. FAST-CTOs Patient Demographics Vessels Treated and Refractory Category

14. FAST-CTOs CTO Characteristics
Vessel
Measure
FAST-CTOs1
(n=147)
Crosser
(n=125)
JCTO
Registry
(n=498)
NHLBI Registry1,2
(n=64)
Baseline RVD
2.9 ± 0.4
2.9 ± 0.6
2.9 ± 0.7
CTO Length
(Range)
32 ± 20
(3-100)
23 ± 13
(-)
14 ± 13
22 ± 14
Calcification
34%
65%
55%
28%
Tortuosity
41% 3% -
30%
>45˚ Angulation
25%
31%
45%
Side Branches
33%
66%
79%
Bridging Collaterals
37%
43%
22%

15. Technical Success by Study Experience the learning curve%

16. Technical Success by Lesion Length

17. FAST CTOs Adverse Events % This is the Bulleted List slide.
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18. FAST-CTOs Results Procedure/Fluoroscopy Time
Measure
FAST-
CTOs
(n=147)
min
Historical
Control
(n=661)
JCTO
Registry
(n=498)
Crosser
(n=125)
Proc Time
Mean ± SD
Median (Range)
105 ± 54
96 (17-332)
146 -
108
Fluoro Time
44 ± 25
41 (5-163) 53
45 (1-301) 44

19. FAST-CTOs Compared to Other CTO IDE Studies
Endpoint
FAST-CTOs
Crosser1
SafeCross2
Frontrunner3
# of Patients
147
125
116
107
Tech Success
77%
61%
54%
56%
30-Day MACE
4.8%
8.8%
6.9% 8%
CTO Length (Range)
31.6
(3-100)
23.4 (≤305)
27.14
(6-80)
21.5
(≤255)
1 Tiroch, et al, Catheter Cardiovasc Interv 2008; 72:
2 Baim, et al, Am J Cardiol 2004;94:853–858
3Whitlow, et al, J Am Coll Cardiol 2002;39:29A [Abstract]
4 Reported as “narrowing length”
5 Protocol exclusion criterion

20. FAST-CTOs Compared to Other CTO Registries
Endpoint
FAST-CTOs
J-CTO
Registry1
NHLBI
Registry2
# of Patients
147 54 64
Tech Success
77%
72%3
72%
30-Day MACE
4.8%
2.4%4 -
CTO Length (Range)
31.8
(3-100)
13.5
(-)
22.44
1 Morino, et al, JACC Cardiovasc Interv Feb;3(2):152-4
2 Abbott, et al, Am J Cardiol 2006;97:1691–1696
3 Includes only “retry” CTOs4 Includes all 498 patients
5 Reported as “lesion length”

21. FAST-CTOs Conclusions
The BridgePoint Medical CTO System is safe and effective in the treatment of coronary epicardial chronic total occlusions
Procedure time with the System is shorter with lower fluoroscopy times compared to historical controls
The Bridgepoint Medical CTO system’s effectiveness, safety, and efficiency compares favorably with other investigated devices and techniques for therapy of CTO