Initial Experience with the L STREAM Vascular Covered Stent · • Dr. Holden has been compensated...
Transcript of Initial Experience with the L STREAM Vascular Covered Stent · • Dr. Holden has been compensated...
Initial Experience with the LIFESTREAM™ Balloon Expandable
Vascular Covered Stent
Andrew Holden, MBChB, FRANZCRDirector of Interventional Radiology
Auckland City Hospital, Auckland New Zealand
BPV/SGF1/1016/0007
CAUTION: Investigational Device - Limited by Federal (USA) Law to Investigational Use
FinalresultsoftheBOLSTERstudy:Aprospective,multicenter studyofa
balloon-expandableePTFE-coveredstentforobstructivelesionsintheiliacartery
AndrewHolden
AucklandHospital
Auckland,NewZealand
LINC2017– 26th January2017
Disclaimers
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• This presentation is being made on behalf of Bard Peripheral Vascular, Inc.
• The clinical data and information presented herein are preliminary with ongoing follow-up through the study. In certain instances, these data are subject to change upon completion of all follow-up visits.
• Caution: The LIFESTREAM™ Balloon Expandable Vascular Covered Stent is an investigational device, limited by United States law to investigational use.
• Dr. Holden has been compensated by Bard Peripheral Vascular, Inc. to participate in this presentation.
BPV/SGF1/1016/0007
CAUTION: Investigational Device - Limited by Federal (USA) Law to Investigational Use
Disclosure
Speaker name:
Andrew Holden
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 interestX
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• Electropolished 316L stainless steel stent, dual layer ePTFE
• Pre-mounted on non-compliant balloon, 0.035” guidewire
• Radiopaque markers on balloon shaft indicate ends of covered stent
6F 7F 8F
80cm, 135cm catheters
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Balloon Expandable Vascular Covered Stent in the Treatment of Iliac Artery Occlusive Disease
Design
Objective
ITT Population
Core Laboratories
Prospective, Multi-Center, Non-Randomized, Single-Arm Study
Assess the safety and effectiveness of the LIFESTREAM™ Balloon Expandable Vascular Covered Stent for the treatment of stenosesand occlusions in the common and/or external iliac arteries
155 patients at 17 investigational sites (US, Europe, New Zealand)
– Angiographic Core Lab: Yale Cardiovascular Research Group
– Duplex Ultrasound Core Lab: VasCore
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CAUTION: Investigational Device - Limited by Federal (USA) Law to Investigational Use
CEC Independent Clinical Events Committee – monitor MAEs
Investigators & Centers
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J. R. Laird, Sacremento, CA
F. Elmasri, Lakeland, FL
D. R. Doucet, Worcester, MA
R. E. Beasley, Miami Beach, FL
E. Moore, Jacksonville, FL
D. M. Mego, Little Rock, AR
S. Marica, Sayre, PA
R. Mendes, Raleigh, NC
R. M. Bersin,Seattle, WA
S. W. Kujath,Kansas City, MO
M Razavi,Orange County, CA
T. Zeller, Freiburg-Bad Krozingen, Germany
R Schmiedel,Kaiserslautern, Germany
J Teßarek, Lingen, Germany
D. Scheinert,Leipzig, Germany
J Stegemann, Berlin, Germany
A Holden, Auckland, New Zealand
17 Centers in the U.S., Europe, and New Zealand Enrolled 155 Patients
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CAUTION: Investigational Device - Limited by Federal (USA) Law to Investigational Use
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Primary Endpoint
Composite safety and effectiveness measure defined as • Device and/or procedure-related death or MI through 30 days, or• Any TLR, major limb amputation, or restenosis (DUS) through 9-months
The primary endpoint is evaluated against a Performance Goal of 19.5%, which was derived from iliac stent published literature.
BPV/SGF1/1016/0007
CAUTION: Investigational Device - Limited by Federal (USA) Law to Investigational Use
• Technical Success – successful delivery/deployment of endograft• Procedure Success – residual stenosis < 30% without peri-procedural complication• TLR / TVR• Primary Patency – freedom from restenosis > 50% by DUS AND/OR TLR
Secondary EndpointsIncluded:
• Rutherford 2-4
• Non-stented iliac lesions ≥50% stenosed
• RVD of 4.5mm – 12.0mm
• Target lesion ≤ 100mm
• Ipsilateral / contralateralSFA lesions can be treated
• Unsuccessful pre-dilatation
• Previously stented (bare or covered) lesions
• AAA graft or previous iliac aneurysm
• Occluded ipsilateral SFA and PFA
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• Discharge, 30-days, 9-, 12-, 24-, and 36-months• Physical exam, duplex ultrasound, ABI
Inclusion Criteria Exclusion Criteria
Clinical Assessment
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included… included…
Baseline Demographics
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BPV/SGF1/1016/0007
CAUTION: Investigational Device - Limited by Federal (USA) Law to Investigational Use
ITT Group
Number of Patients 155
Age, years 64.3 + 9.75
Male/Female, % 69/31
Weight , kg 79.6 + 16.6
BMI, kg/m2 27.2 + 4.8
Medical History
Hypertension, % (n) 75.5 (117)
Dyslipidemia, % (n) 65.2 (101)
CAD, % (n) 31.6 (49)
Smoker, % (n) 85.2 (132)
Diabetes, % (n) 32.3 (50)
Previous MI , % (n) 13.5 (21)
Lesion Characteristics
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BPV/SGF1/1016/0007
CAUTION: Investigational Device - Limited by Federal (USA) Law to Investigational Use
ITT Group
Number of Lesions 197
Mean Lesion Length, mm 29.2 + 17.1
Vessel, % (n)
Common Iliac 73.4 (141)
External Iliac 26.6 (51)
Location, % (n)
Ostial 20.8% (40)
Proximal 59.9% (115)
Moderate/Severe Calcification, % (n) 64.5 (127)
Occlusion, % (n) 10.7 (21)
Pre-% Diameter Stenosis 71.3+ 14.3
Procedure Details
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CAUTION: Investigational Device - Limited by Federal (USA) Law to Investigational Use
ITT Group
Mean Time of Procedure, mins 56.8 + 31.8
Femoral Access , % (n) 98.7 (153)
Ipsilateral Approach, % (n) 53.5 (83)
Number of Stent Grafts Placed 230
Max Pressure of Balloon Inflation, atm 9.8 + 1.9
Stent Graft Placement, % (n*)
Single Stent Graft 68.1 (156)
Overlap 11.4 (26)
“Kissing” 10.5 (24)
Tandem/Separate 10.0 (23)
Final % Diameter Stenosis 11.2 + 5.9
Technical Success, % (95% CI) 98.3% (95.6, 99.5)
Case Study # 1
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• 68 year old male, TASC A Lesion
• Left leg claudication, Rutherford 3
Courtesy: Dr. Andrew Holden
Case Study # 1
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Case Study # 1
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Case Study # 1
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• DUS @ 6 months
Case Study # 2
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• 74 year old male, TASC B Lesions
• Bilateral leg claudication, Rutherford 3
Courtesy: Dr. Andrew Holden
Case Study # 2
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Case Study # 2
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Case Study # 2
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Case Study # 3
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• 66 year old male, TASC B Lesion
• Right leg claudication, Rutherford 3
Courtesy: Dr. Andrew Holden
Case Study # 3
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Case Study # 3
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Case Study # 3
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Results: 9 Months
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BPV/SGF1/1016/0007
CAUTION: Investigational Device - Limited by Federal (USA) Law to Investigational Use
Endpoints ITT Group(95% CI)
p- value
Acute Procedural Success+, % 97.4 (148/152) 93.4, 99.3
> 30% Residual Stenosis 1.3 (2/152)
Not Successfully Delivered 1.3 (2/152)
Peri-Procedural Complication 0.7 (1/152)
Primary Composite Endpoint^, % (Performance Goal < 19.5%)
11.6 (16/138) (7.0, 17.8)
p=0.01*
Major Amputation 0.7 (1/138)
TLR 4.3 (6/138)
Restenosis 7.2 (10/138)
Primary Patency** 89.1 (122/137) (82.6, 93.7)
+5 events in 4 patients;
^17 patients were not evaluated (death, withdrawal, lost to follow up, or did not have 9-month imaging) *One-sided, exact binomial test; **Proportional –based analyses at 9 months
Freedom From TLR
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BPV/SGF1/1016/0007
CAUTION: Investigational Device - Limited by Federal (USA) Law to Investigational Use
96.7%(270 days)
TimeSurvival %
[95% CI]
Subject
with
Event
Censored
Subjects
Subjects
at Risk
0 days 0.0% [100, 100.0] 0 0 155
180 days 98.1% [94.1, 99.4] 3 1 151
270 days 96.7% [92.3, 98.6] 5 12 138
Change in Rutherford Score
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BPV/SGF1/1016/0007
CAUTION: Investigational Device - Limited by Federal (USA) Law to Investigational Use
ITT Rutherford Classification (N=155)
Rutherford Category Baseline 9 Months*
Category 0 0 59.9% (82/137)
Category 1 0 21.9% (30/137)
Category 2 15.5% (24/155) 10.2% (14/137)
Category 3 76.1% (118/155) 0
Category 4 8.4% (13/155) 0
Mean Category (SD) 2.9 + 0.5 0.7 + 1.0
Change From
Baseline- -2.2 + 1.2
Improved
1 Category - 13.1% (18/137)
2 Category - 22.6% (31/137)
3-4 Category - 54.7% (75/137)
*Three patients were reported worsened, including one patient listed as category 6
Conclusions
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• The LifeStream Vascular Covered Stent was successfully deployed in
98.3% of cases (technical success), with an acute procedural success
rate of 97.4%.
• The primary composite endpoint was significantly less than the
historical performance goal (p=0.01)
– The rate of device and/or procedure-related death or MI through 30 days, or any
TLR, major limb amputation, or restenosis was 11.6% vs. 19.5% (Performance
Goal)
• Primary Patency: 89.1%
• Freedom from TLR: 96.7%
The BOLSTER prospective, multicenter, international trial is ongoing with
DUS imaging to continue through 3 years.
BPV/SGF1/1016/0007
CAUTION: Investigational Device - Limited by Federal (USA) Law to Investigational Use
Initial Experience with the LIFESTREAM™ Balloon Expandable
Vascular Covered Stent
Andrew Holden, MBChB, FRANZCRDirector of Interventional Radiology
Auckland City Hospital, Auckland New Zealand
BPV/SGF1/1016/0007
CAUTION: Investigational Device - Limited by Federal (USA) Law to Investigational Use
FinalresultsoftheBOLSTERstudy:Aprospective,multicenter studyofa
balloon-expandableePTFE-coveredstentforobstructivelesionsintheiliacartery
AndrewHolden
AucklandHospital
Auckland,NewZealand
LINC2017– 26th January2017