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


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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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

BPV/SGF1/1016/0007


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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


• 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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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


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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BPV/SGF1/1016/0007


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

11CAUTION: Investigational Device - Limited by Federal (USA) Law to Investigational Use

BPV/SGF1/1016/0007

• 68 year old male, TASC A Lesion

• Left leg claudication, Rutherford 3

Courtesy: Dr. Andrew Holden

Case Study # 1


BPV/SGF1/1016/0007

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


Case Study # 2


BPV/SGF1/1016/0007

Case Study # 3


BPV/SGF1/1016/0007

• 66 year old male, TASC B Lesion

• Right leg claudication, Rutherford 3


Case Study # 3


BPV/SGF1/1016/0007

Results: 9 Months

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BPV/SGF1/1016/0007


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


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


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


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


FinalresultsoftheBOLSTERstudy:Aprospective,multicenter studyofa

balloon-expandableePTFE-coveredstentforobstructivelesionsintheiliacartery

AndrewHolden

AucklandHospital

Auckland,NewZealand

LINC2017– 26th January2017

initial experience with the l stream vascular covered stent · • dr. holden has been compensated...

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